Diphenhydramine HCL by Innovida Pharmaeutique Corporation

Diphenhydramine HCL by

Drug Labeling and Warnings

Diphenhydramine HCL by is a Otc medication manufactured, distributed, or labeled by Innovida Pharmaeutique Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DIPHENHYDRAMINE HCL- diphenhydramine hcl tablet 
Innovida Pharmaeutique Corporation

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Active Ingredient (in each tablet)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

• runny nose
• itchy, watery eyes
• sneezing
• 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
• difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are
taking sedatives or tranquilizers.

When using this product

• marked drowsiness may occur
• alcohol, sedatives, and tranquilizers may increase drowsiness 
• avoid alcoholic beverages
• use caution 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

• do not take more than directed
• 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 tablets
• children 6 to under 12 years: 1 tablet
• children under 6 years: do not use

Other information

• each tablet contains: calcium 30 mg
• store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
• protect from moisture
• use by expiration date on package

Inactive Ingredients

corn starch, D&C red #27 aluminum lake, dibasic calcium phosphate dihydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide

Product labels

DIPHENHYDRAMINE HCL 
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71800-048
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
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 27 ALUMINUM LAKE (UNII: ZK64F7XSTX)
DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71800-048-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/10/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/10/2025	12/31/2025

Labeler - Innovida Pharmaeutique Corporation (080892908)

Revised: 12/2025

Document Id: 46e1127a-56f6-d87b-e063-6394a90a0a17

34390-5

Set id: 1704006d-5cf1-4dec-bd01-2d9706fccd03

Version: 2

Effective Time: 20251226