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Drug Facts
Diphenhydramine
FDA Label NDC 61010-4409
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Safetec Of America, Inc. for the product Diphenhydramine (NDC 61010-4409). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding other, active ingredient (in each capsule), purpose, uses, do not use, ask a doctor before use if you have, when using this product, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredient (In Each Capsule)
Diphenhydramine HCl 25 mg
Purpose
Antihistamine
Uses
- temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
- runny nose
- sneezing
- itchy, watery eyes
- itching of the nose or throat
- temporarily relieves these symptoms due to the common cold:
- runny nose sneezing
Do Not Use
- to make a child sleepy
- with any other product containing diphenhydramine, even one used on skin
Ask A Doctor Before Use If You Have
- a breathing problem such as emphysema or chronic bronchitis
- glaucoma
- trouble urinating due to an enlarged prostate gland
When Using This Product
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives, and 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.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- take every 4 to 6 hours, or as directed by a doctor
- do not take more than 6 times in 24 hours
| adults and children 12 years and over | 1 to 2 capsules |
| children 6 to under 12 years | 1 capsule |
| children under 6 years | do not use |
Other Information
- each capsule contains: calcium 20 mg
- store at room temperature 20°-25°C (68°-77°F). Avoid high humidity. Protect from light
Inactive Ingredients
benzyl alcohol, butyl paraben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methyl paraben, polysorbate 80, propyl paraben, sodium lauryl sulfate
Questions Or Comments?
Call toll free: 1-800-456-7077
Principal Display Panel - 25 Mg Pouch Label
Safetec
of America, Inc.
DO NOT USE IF POUCH IS TORN OR DAMAGED
Manufactured for Safetec of America, Inc.
Buffalo NY 14215
Allergy Relief
Diphenhydramine HCl
antihistamine 2 Capsules
Principal Display Panel (25 mg Pouch Label)
Principal Display Panel – 50 Pouches Carton Label
Safetec®
of America, Inc.
*Compare to the active ingredient in Benadryl®
NDC 61010-4409-1
Allergy Relief
Diphenhydramine HCl 25 mg
PUSH TO OPEN
Dispense through opening
Antihistamine
- Itchy Watery Eyes
- Sneezing
- Runny Nose
TAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
50 Pouches 2 Capsules per pouch
Principal Display Panel – 50 Pouches Carton Label (Dip0e 0001 02)
Principal Display Panel – 100 Pouches Carton Label
Safetec®
of America, Inc.
*Compare to the active ingredient in Benadryl®
NDC 61010-4409-2
Allergy Relief
Diphenhydramine HCl 25 mg – Antihistamine
- Itchy Watery Eyes
- Sneezing
- Runny Nose
PUSH TO OPEN
Dispense through opening
TAMPER EVIDENT UNIT DOSE POUCHES
DO NOT USE IF POUCH IS TORN OR DAMAGED
100 Pouches 2 Capsules per pouch
Principal Display Panel – 100 Pouches Carton Label (Dip0e 0001 03)
* Please review the disclaimer below.
