DIPHENHYDRAMINE HYDROCHLORIDE capsule, liquid filled

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Diphenhydramine HCl 25mg

PURPOSE

Antihistamine

INACTIVE INGREDIENT

polyethylene glycol 400, propylene glycol, gelatin, glycerin, sorbitol 70%, povidone k-30

DOSAGE & ADMINISTRATION

If needed, repeat dose every 4 to 6 hours donot take more than 6 doses in 24 hours

• Age: Daily dosage
• Adults and children 12 years of age or older: 1 to 2 softgel
• Children 6 to under 12 years: 1 softgel
• Children under 6 years of age: do not use this product

INDICATIONS & USAGE

temporarily relieves these symptoms due to hay fever or other respiratory allergies:

• runny nose
• itching of the nose or throat
• itchy, watery eyes

temporarily relieves these symptoms due to the common cold:

• runny nose
• sneezing

WARNINGS

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

• 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

• 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, expecially in children

If pregnant or breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.

OVERDOSAGE

Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

OTHER SAFETY INFORMATION

• store between 20-25°C (68-77ºF), Excursions permitted between 15°C-30°C (59-86ºF).
• TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride capsule, liquid filled

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-783
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	25 mg

Inactive Ingredients
Ingredient Name	Strength
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
SORBITOL (UNII: 506T60A25R)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
GELATIN (UNII: 2G86QN327L)
POVIDONE K30 (UNII: U725QWY32X)

Product Characteristics
Color	white (Natural Transparent)	Score	no score
Shape	OVAL (Oblong)	Size	14mm
Flavor		Imprint Code	783
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-783-02	20 in 1 BLISTER PACK; Type 0: Not a Combination Product	08/20/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/20/2018

Labeler - Strive Pharmaceuticals Inc. (080028013)