CVS DIPHENHYDRAMINE HYDROCHLORIDE- diphenhydramine hydrochloride tablet

CVS Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

CVS Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by CVS Pharmacy, Cabinet Health P.B.C.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each tablet)

Diphenhydramine Hydrochloride 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

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

 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.

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 doses in 24 hours

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

Other information

• store between 20°–25°C (68°–77°F)
• protect from moisture and light

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red #27 Al lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide.

Questions or comments?

Call 1-800-SHOP CVS

Package Labeling:

INGREDIENTS AND APPEARANCE

CVS DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-191
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
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	CAPSULE	Size	12mm
Flavor		Imprint Code	S4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-191-00	365 in 1 BOTTLE; Type 0: Not a Combination Product	10/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	10/01/2025

Labeler - CVS Pharmacy (062312574)

Registrant - Cabinet Health P.B.C. (117102391)