DIPHENHYDRAMINE HYDROCHLORIDE tablet

Diphenhydramine Hydrochloride by

Drug Labeling and Warnings

Diphenhydramine Hydrochloride by is a Otc medication manufactured, distributed, or labeled by Bi-Mart, Health Pharma USA LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:  

     o runny nose

     o sneezing

     o itchy, watery eyes

     o itchy of the nose or throat

• temporarily relieves these symptoms of the common cold:

    o runny nose
    o 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 
• a breathing problem such as emphysema or chronic bronchitis
• difficulty in urination due to  enlargement of the prostate gland

Ask a doctor or pharmacist before use if youaretaking sedatives or tranquilizers

When using this product

• marked drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives and othe tranquilizers may increase drowsiness
• 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 (1-800-222-1222) right away.

Directions

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

• adults and children 12 years and over:1 or 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
• each tablet contains:phosphorus 15 mg
• store  at room temperature
• protct from moisture
• DO NOT USE IF  PRINTED SEAL UNDER CAP IS MISSING OR DAMAGED.

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, phloxine B lake, polyethylene glycol, polyvinyl alcohol, stearic acid, talc, titanium dioxide.

Questions?

call toll free 1-844-912-4012

PRINCIPAL DISPLAY PANEL

NDC: 37835-641-01

Compare to the active ingredients in Benadryl ®Allergy ULTRATAB ®Tablets.*

Allergy Medicine

Antihistamine

Diphenhydramine HCl 25 mg

100 Tablets

*This product is not manufactured or distributed by the owner of the registered trademark Benadryl ®Allergy ULTRATAB ®Tablets.

Distributed by:

BI-MART

Eugene, OR 97402

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HYDROCHLORIDE 
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-641
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
D&C RED NO. 28 (UNII: 767IP0Y5NH)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	D25
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-641-01	100 in 1 BOTTLE; Type 0: Not a Combination Product	02/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	02/01/2025

Labeler - Bi-Mart (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
Health Pharma USA LLC		080804485	manufacture(37835-641)