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Allergy Antihistamine by Select Corporation

Medically reviewed on October 16, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Select Corporation
NDC Code: 52904-460

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.

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

ALLERGY ANTIHISTAMINE  
diphenhydramine hydrochloride tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52904-460
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
TITANIUM DIOXIDE 
POLYSORBATE 80 
CARNAUBA WAX 
POLYETHYLENE GLYCOL 300 
CELLULOSE, MICROCRYSTALLINE 
MAGNESIUM STEARATE 
CROSCARMELLOSE SODIUM 
SILICON DIOXIDE 
LACTOSE 
D&C RED NO. 27 
Product Characteristics
Colorpink (rose pink) Scoreno score
ShapeCAPSULE (T;061) Size11mm
FlavorImprint CodeT;061
Contains    
Packaging
#Item CodePackage Description
1NDC:52904-460-022 TABLET (TABLET) 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)

 
Select Corporation

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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