DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25mg
Diphenhydramine Hydrochloride by
Drug Labeling and Warnings
Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Qualitest Pharmaceuticals, Advance Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride capsule
Qualitest Pharmaceuticals
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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DIPHENHYDRAMINE HYDROCHLORIDE CAPSULES, USP 25mg
Uses
temporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- runny nose
- itchy nose or throat
- sneezing
- itchy, watery eyes
WARNINGS
Do not use with any other product containing diphenhydramine, even one used on skin
Ask a doctor before use if you have
- glaucoma
- trouble urinating due to an enlarged prostate gland
- a breathing problem such as emphysema or chronic bronchitis
Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers
When using this product
- you may get very drowsy
- avoid alcoholic drinks
- alcohol, sedatives & tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
- adults and children 12 years and over: take 1 to 2 capsules every 4-6 hours; not more than 6 doses in 24 hours
- children under 12 years: ask a doctor
Other Information
- store at 15-30 °C (59-86 °F)
- protect from moisture
- For 1000 Count: This is a bulk package. Dispense contents in a tight, light-resistant container with a child-resistant closure as defined in the USP
Inactive Ingredients
benzyl alcohol, butylparaben, D&C red# 28, edible black ink, FD&C bule #1, FD&C red# 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium laurel sulfate
Questions or Comments
TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP OR BAND AROUND ANY CAPSULE IS MISSING OR DAMAGED
Distributed by: Qualitest Pharmaceuticals, Inc.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DIPHENHYDRAMINE HYDROCHLORIDE CAPSULE, USP 25 MG
ANTIHISTAMINE
NDC: 0603-3339-21 – 100 COUNT
NDC: 0603-3339-32 – 1000 COUNT (THIS PACKAGE FOR HOUSEHOLDS WITHOUT YOUNG CHILDREN)
| DIPHENHYDRAMINE HYDROCHLORIDE
diphenhydramine hydrochloride capsule |
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| Labeler - Qualitest Pharmaceuticals (011103059) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Advance Pharmaceutical, Inc. | 078301063 | MANUFACTURE(0603-3339) | |