DIPHENHYDRAMINE HYDROCHLORIDE 25MG tablet

Diphenhydramine Hydrochloride 25mg by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride 25mg by is a Otc medication manufactured, distributed, or labeled by Strive Pharmaceuticals Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

 temporarily relieves these symptoms due to hay fever or upper respiratory allergies:
       runny nose              sneezing
       itchy, watery eyes  itching of the nose and throat
 temporarily relieves these symptoms due to the common cold:
      runny nose              sneezing

Warnings

Do not use
 to make a child sleepy
 with other products containing diphenhydramine, even ones 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

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, especially in children

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

Keep out of reach of children.
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.

Directions

take every 4 to 6 hours, or as directed by doctor
do not take more than 6 times in 24 hours

• adults & children 12 years of age and over: take 1 to 2 tablets
• children 6 years of age to under 12 years of age: take 1 tablet
• children under 6 years of age: do not use

Other information

 each tablet contains: calcium 18.64 mg
 store at room temperature between 20 - 25°C (68-77°F).
 avoid excessive heat, cold and humidity.
 close cap tightly after use.

Inactive ingredients

croscarmellose sodium, dicalcium phosphate, D&C red #27 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, talc, titanium dioxide

Questions or comments?

1-888-577-8033 Monday - Friday 8am - 4pm EST

SPL UNCLASSIFIED SECTION

RIGHT REMEDIES

Compare to the active ingredient of Benadryl® Allergy Ultratabs®*

Distributed by: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816

Product of India

Packaged & Quality Assured in USA

REV.00-102022

READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

*This product is not manufactured or distributed by Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division., owner of the registered trademark Benadryl® Allergy Ultratabs®

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL UNDER CAP IS BROKEN OR MISSING FROM BOTTLE

Packaging

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 25MG 
diphenhydramine hydrochloride 25mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 70692-148
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
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C RED NO. 27 (UNII: 2LRS185U6K)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	DP
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 70692-148-01	100 in 1 PACKAGE; Type 0: Not a Combination Product	12/28/2018
2	NDC: 70692-148-46	1 in 1 CARTON	04/06/2023
2		72 in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	12/20/2018

Labeler - Strive Pharmaceuticals Inc (080028013)