ALLERGY ANTIHISTAMINE- diphenhydramine hydrochloride tablet

Allergy Antihistamine by

Drug Labeling and Warnings

Allergy Antihistamine by is a Otc medication manufactured, distributed, or labeled by Select Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients

Diphenhydramine HCl 25 mg

PURPOSE

Antihistamine

DOSAGE & ADMINISTRATION

Directions take every 4 to 6 hours do
not take more than 6 doses in 24 hours Adults
and children 12 years of age and over: 1 to 2
caplets Children 6 to under 12 years of age: 1
caplet children under 6 years of age: do not use
this product in children under 6 years of age

INDICATIONS & USAGE

Uses: temporarily relieves these symptoms due to hay fever
or other upper respiratory allergies: runny nose sneezing
itchy, watery eyes itchy nose or throat temporarily relieves
these symptoms due to the common cold: runny nose
sneezing

WARNINGS

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 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.

PREGNANCY OR BREAST FEEDING

If pregnant or
breast-feeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN.

INACTIVE INGREDIENT

Inactive ingredients: carnauba wax,
colloidal silicon dioxide, croscarmellose sodium, DC red 27
aluminum lake, dibasic calcium phosphate dihydrate,
hydroxypropylmethyl cellulose, hypromellose, lactose,
magnesium stearate, microcrystalline cellulose, polyethylene
glycol (PEG) 400, polysorbate 80, silicon dioxide, titanium
dioxide

PRINCIPAL DISPLAY PANEL

MM1

INGREDIENTS AND APPEARANCE

ALLERGY ANTIHISTAMINE  
diphenhydramine hydrochloride tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 52904-460
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
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
LACTOSE (UNII: J2B2A4N98G)
D&C RED NO. 27 (UNII: 2LRS185U6K)

Product Characteristics
Color	pink (rose pink)	Score	no score
Shape	CAPSULE (T;061)	Size	11mm
Flavor		Imprint Code	T;061
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52904-460-02	2 in 1 PACKET

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/15/2012

Labeler - Select Corporation (053805599)

Registrant - Select Corporation (053805599)