ALLERGY ANTIHISTAMINE  - diphenhydramine hydrochloride tablet 
Select Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

Diphenhydramine HCl 25 mg

Antihistamine

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

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: 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.

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

KEEP OUT OF REACH OF CHILDREN.

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

MM1

antihistamine packet

ALLERGY ANTIHISTAMINE  
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-460
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorpink (rose pink) Scoreno score
ShapeCAPSULE (T;061) Size11mm
FlavorImprint Code T;061
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52904-460-022 in 1 PACKET
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34110/15/2012
Labeler - Select Corporation (053805599)
Registrant - Select Corporation (053805599)

Revised: 10/2012
Document Id: 249fe75a-9f9e-4e59-985b-b49fe3c3c60f
Set id: ba0ecb7f-9389-44af-98ed-a2c41c793ef8
Version: 1
Effective Time: 20121015
 
Select Corporation