DIPHENHYDRAMINE- diphenhydramine hcl tablet, coated

diphenhydramine by

Drug Labeling and Warnings

diphenhydramine by is a Otc medication manufactured, distributed, or labeled by Sam's West Inc, LNK International, Inc.. 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:
  • 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

• 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

• 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.

Directions

• 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

• store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF)
• protect from moisture
• use by expiration date on package

Inactive ingredients

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

Questions or comments?

1-800-426-9391 8:30 AM to 4:00 PM ET, Monday-Friday

Principal Display Panel

Compare to Benadryl® Allergy
Ultratab® active ingredient*

Member's Mark®
QUALITY GUARANTEED

NDC: 68196-929-78

diphenhydramine
diphenhydramine HCl
25 mg
antihistamine

For allergy relief of
sneezing
runny nose
itchy, watery eyes
itchy throat or nose

actual
size

600
Tablets

Comments or Questions?
Call 1-800-426-9391
from 8:30 a.m. to 4:00 p.m. ET
Monday - Friday

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

*This product is not manufactured or distributed by McNeil
Consumer Healthcare, owner of the registered trademark
Benadryl® Allergy Ultratab®.         50844     ORG051232978

DISTRIBUTED BY: SAM'S WEST, INC., BENTONVILLE, AR  72716

Members Mark 44-329

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE 
diphenhydramine hcl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68196-929
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)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)

Product Characteristics
Color	PINK	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	44;329
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68196-929-78	600 in 1 BOTTLE; Type 0: Not a Combination Product	03/02/1990

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part341	03/02/1990

Labeler - Sam's West Inc (051957769)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		868734088	MANUFACTURE(68196-929) , PACK(68196-929)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867837	PACK(68196-929)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		967626305	PACK(68196-929)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		038154464	PACK(68196-929)

Establishment
Name	Address	ID/FEI	Business Operations
LNK International, Inc.		832867894	MANUFACTURE(68196-929)