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Diphenhydramine 12.5Mg-5Ml Sol 118 Ml

  • Manufacturer Name : Major
  • MFG # : 00904698520
  • NDC : 00904698520
  • Distributor Name : AmeriSource Bergen
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Product Properties:

Description Diphenhydramine HCl, 50 MG
DESI Drug Ind -
DESI2 Drug Ind -
Drug Category N
Drug Type Code 2
FDA Approval Date 08/27/2019
FDA Therap Equiv NR
HCPCS Q0163
Market Entry Date 10/09/2019
Medical Coverage COVERED WITH SPECIAL INSTRUCTIONS
Termination Date -
Unit ML
Units Per Pkg 118
Active Ingredients 3369 diphenhydramine HCl 147240
AHFS Class 4040400 ETHANOLAMINE DERIVATIVES; 48040400 FIRST GENERATION ANTIHIST.(RESPIR TRACT); 4040000 FIRST GENERATION ANTIHISTAMINES
DEA Class NC
Dose Form LIQUID (ML)
Fine Line Class 070007700779 Gnrc Children's Cold Allergy
Gen Code and Des 16675 diphenhydramine HCl ORAL LIQUID 12.5MG/5ML
Inactive Ingredients 10093 corn syrup 8029434; 10141 red dye; 2332 sodium citrate 68042; 2598 sucrose 57501
OMP Family -
Product Category OT Over the Counter
Strength 12.5MG-5ML
Common Brand Name COMMON BRAND NAME(S): Benadryl, Genahist, Naramin, Sominex, Unisom
Drug Interaction DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval. Some products that may interact with this drug include: antihistamines applied to the skin (such as diphenhydramine cream, ointment, spray). Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or other antihistamines (such as cetirizine, chlorpheniramine). Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely. This medication may interfere with certain lab tests (such as allergy skin test), possibly causing false test results. Make sure lab personnel and all your doctors know you use this drug.
Allocation Period -
Case Quantity 36
Drug Form Pack Size 118
Form SOLUTION
Hazard Code -
Listed Chemical -
NIOSH Code -
Orange Book ZA Particular pharmaceutical entity (GCN) looked at but particular labeler was not evaluated.
Retail Pack Quantity 1
Returnable Status Returnable
Special Storage Cond 00 None
Temp Zone 10 Room Temperature
Unit EA
Unit Size 118
How to Use HOW TO USE: Follow all directions on the product package. If your doctor has prescribed this medication, take it as directed. If you have any questions, ask your doctor or pharmacist. Take the tablet, capsule, or liquid form by mouth with or without food. Measure liquid forms of this medication using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose. If you have a single-dose form of this medication (such as a single-use whistle), you do not need to measure the dose. The rapidly-dissolving tablet or strip should be allowed to dissolve on the tongue and then swallowed, with or without water. The chewable tablets should be chewed thoroughly before being swallowed. The dosage is based on your age, medical condition, and response to treatment. There are many brands and forms of diphenhydramine available. Read the dosing instructions carefully for each product because the amount of diphenhydramine may be different between products. Do not increase your dose or take this medication more often than directed. To prevent motion sickness, take your dose 30 minutes before starting activity such as travel. To help you sleep, take your dose about 30 minutes before bedtime. If you continue to have difficulty sleeping for longer than 2 weeks, contact your doctor. Tell your doctor if your condition does not improve or if it worsens.
Missed Dose MISSED DOSE: If you miss a dose, take it as soon as you remember. If it is near the time of your next dose, skip the missed dose. Take your next dose at the regular time. Do not double the dose to catch up.
Notes NOTES: Keep all medical and lab appointments.
Overdose OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness, seizures, widened pupils. In children, mental/mood changes (such as restlessness, irritability, hallucinations) may occur before drowsiness.
Phonetic Pronunciation (DYE-fen-HYE-dra-meen)
Precautions PRECAUTIONS: Before taking diphenhydramine, tell your doctor or pharmacist if you are allergic to it; or to dimenhydrinate; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: breathing problems (such as asthma, emphysema), high pressure in the eye (glaucoma), heart problems, high blood pressure, liver disease, seizures, stomach/intestine problems (such as ulcers, blockage), overactive thyroid (hyperthyroidism), difficulty urinating (for example, due to enlarged prostate). This drug may make you dizzy or drowsy or blur your vision. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness or clear vision until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis). Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). Liquid products, chewable tablets, or dissolving tablets/strips may contain sugar and/or aspartame. Liquid products may also contain alcohol. Caution is advised if you have diabetes, liver disease, phenylketonuria (PKU), or any other condition that requires you to limit/avoid these substances in your diet. Ask your doctor or pharmacist about using this product safely. Children may be more sensitive to the side effects of this drug. This drug can often cause excitement in young children instead of drowsiness. Older adults may be more sensitive to the side effects of this drug, especially drowsiness, dizziness, confusion, constipation, or trouble urinating. Drowsiness, dizziness, and confusion can increase the risk of falling. During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
Side Effects SIDE EFFECTS: Drowsiness, dizziness, constipation, stomach upset, blurred vision, or dry mouth/nose/throat may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly. To relieve dry mouth, suck (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute. If your doctor has directed you to use this medication, remember that your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if you have any serious side effects, including: mental/mood changes (such as restlessness, confusion), difficulty urinating, fast/irregular heartbeat. Get medical help right away if you have any very serious side effects, including: seizures. A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Storage STORAGE: Store at room temperature away from moisture and light. Do not store in the bathroom. Do not freeze liquid forms of this medication. Keep all medications away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.
Uses USES: Diphenhydramine is an antihistamine used to relieve symptoms of allergy, hay fever, and the common cold. These symptoms include rash, itching, watery eyes, itchy eyes/nose/throat, cough, runny nose, and sneezing. It is also used to prevent and treat nausea, vomiting and dizziness caused by motion sickness. Diphenhydramine can also be used to help you relax and fall asleep. This medication works by blocking a certain natural substance (histamine) that your body makes during an allergic reaction. Its drying effects on such symptoms as watery eyes and runny nose are caused by blocking another natural substance made by your body (acetylcholine). Cough-and-cold products have not been shown to be safe or effective in children younger than 6 years. Do not use this product to treat cold symptoms in children younger than 6 years unless specifically directed by the doctor. Some products (such as long-acting tablets/capsules) are not recommended for use in children younger than 12 years. Ask your doctor or pharmacist for more details about using your product safely. These products do not cure or shorten the length of the common cold and may cause serious side effects. To decrease the risk for serious side effects, carefully follow all dosage directions. Do not use this product to make a child sleepy. Do not give other cough-and-cold medication that might contain the same or similar ingredients (see also Drug Interactions section). Ask the doctor or pharmacist about other ways to relieve cough and cold symptoms (such as drinking enough fluids, using a humidifier or saline nose drops/spray).

Frequently Asked Questions(FAQs)

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Diphenhydramine 12.5Mg-5Ml Sol 118 Ml is manufactured by Major.
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