DIPHENHYDRAMINE HCL MAXIMUM STRENGTH- diphenhydramine hcl tablet

Diphenhydramine HCl by

Drug Labeling and Warnings

Diphenhydramine HCl by is a Otc medication manufactured, distributed, or labeled by Bi-Mart, L.N.K. International, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each caplet)

Diphenhydramine HCl 50 mg

Purpose

Nighttime sleep-aid

Use

helps reduce difficulty falling asleep

Warnings

Do not use

• in children under 12 years of age
• with any other product containing diphenhydramine, even one used on skin
• with other antihistamines

Ask a doctor before use if you have

• glaucoma
• a breathing problem such as emphysema or chronic bronchitis
• 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

• avoid alcoholic beverages
• be careful when driveing a motor vehicle or operating machinery

Stop use and ask a doctor if

sleeplessness persists continuously for more than 2 weeks. Insomnia may be a symptom of a serious underlying medical illness.

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

• adults and children 12 years of age and over: take 1 caplet at bedtime if needed, or as directed by your doctor
• children under 12 years: do not use

Other information

• each caplet contains:calcium 50 mg
• store at room temperature
• protect from moisture

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, dicalcium calcium phosphate dihydrate, FD&C blue #1 aluminum lake, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, silicon dioxide, stearic acid, talc, titanium dioxide, yellow iron oxide

Questions?

call toll free 1-844-912-4012

SPL UNCLASSIFIED SECTION

Distributed by:

BI-MART

Eugene, OR 97402

Principal Display Panel

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE HCL   MAXIMUM STRENGTH
diphenhydramine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37835-852
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	50 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 ALUMINUM LAKE (UNII: J9EQA3S2JM)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYVINYL ALCOHOL (UNII: 532B59J990)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)

Product Characteristics
Color	blue	Score	no score
Shape	OVAL (caplet)	Size	15mm
Flavor		Imprint Code	44;687
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37835-852-50	50 in 1 BOTTLE; Type 0: Not a Combination Product	05/01/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M010	05/01/2025

Labeler - Bi-Mart (027630078)

Registrant - Bi-Mart (027630078)

Establishment
Name	Address	ID/FEI	Business Operations
L.N.K. International, Inc.		038154464	manufacture(37835-852)