DIPHENHYDRAMINE- diphenhydramine hydrochloride tablet, coated

Diphenhydramine by

Drug Labeling and Warnings

Diphenhydramine by is a Otc medication manufactured, distributed, or labeled by AAA Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

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
  • 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 with any other product containing diphenhydramine, even one used on skin

Ask a doctor before use if you have

• glaucoma
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

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
• excitability may occur, especially in children
• be careful when driving a motor vehicle or operating machinery

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
• do not exceed 6 doses in 24 hours

* 12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.
adults and children 12 years of age and over	25 mg to 50 mg (1 to 2 tablets)
children 6 to under 12 years of age	12.5 mg * to 25 mg (1 tablet)
children under 6 years of age	ask a doctor

Other information

• each tablet contains: calcium 45 mg
• store at room temperature 15°-30°C (59°-86°F)
• retain carton for complete product information

Inactive ingredients

colloidal silicon dioxide, croscarmellose sodium, D&C red #27, dibasic calcium phosphate, FD&C yellow #6, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polysorbate 80, titanium dioxide

PRINCIPAL DISPLAY PANEL

RESTORE U

NDC: 57344-090-02

†COMPARE TO THE ACTIVE INGREDIENT IN BENADRYL® ALLERGY ULTRATABS®

Allergy Relief

Antihistamine 
Diphenhydramine HCl

Easy To Swallow

Relieves: Sneezing Runny Nose 
Itchy, Watery Eyes Itchy Throat

48 TABLETS

INGREDIENTS AND APPEARANCE

DIPHENHYDRAMINE 
diphenhydramine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 57344-090
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)
D&C RED NO. 27 (UNII: 2LRS185U6K)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	pink	Score	no score
Shape	OVAL	Size	11mm
Flavor		Imprint Code	25;052
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 57344-090-02	4 in 1 CARTON	04/13/2012
1		12 in 1 BLISTER PACK; Type 0: Not a Combination Product
2	NDC: 57344-090-03	1 in 1 CARTON	11/27/2017
2		100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	04/13/2012

Labeler - AAA Pharmaceutical, Inc. (181192162)