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DIPHENHYDRAMINE HYDROCHLORIDE by Time-Cap Labs, Inc

Medically reviewed on October 25, 2017

Dosage form: tablet, coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Time-Cap Labs, Inc
NDC Code: 49483-329

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.

Active Ingredient

(in each caplet)

Diphenhydramine Hcl 25 mg

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.

Do not use

to make a child sleepy; with any other product containing diphenhydramine, even one used on skin.

Keep out of reach of children.  In case of overdose, get medical help or contact a Poison Control Center right away.

      Warnings

Do not use to make a child sleepy; Do not use with any other product containing diphenhydramine even one used on skin.


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

Uses temporarily relieves these symptoms due to hay fever or other upper respiratory allergies

runny nose; itchy water eyes sneezing;itchy nose or throat

Temporarily relieves these symptoms due to the common cold: runny nose; sneezing

When using this product

Avoid alcoholic drinks

marked drowsiness may occur

Alcohol, sedatives, and tranquilizers may increase drowsiness

Excitability may occur, especially in children

Be careful when driving a motor vehicle or operating machinery


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

Carnauba Wax, Colloidal Silicon Dioxide, Croscarmellose Sodium, Dibasic Calcium Phosphate Dihydrate, Hypromellose, Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol, Polysorbate 80, Titanium Dioxide

Uses: Temporarily relieves these symptoms due to hay fever or other upper respiratory allergies; runny nose, itchy watery eyes; sneezing; itchy nose or throat

Temporarily relieves these symptoms due to the common cold:  runny nose; sneezing

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DIPHENHYDRAMINE HYDROCHLORIDE  
diphenhydramine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-329
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE ) DIPHENHYDRAMINE HYDROCHLORIDE 25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
HYPROMELLOSES  
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorwhiteScoreno score
ShapeCAPSULESize7mm
FlavorImprint Codehelp
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-329-00100000 TABLET, COATED (TABLET) in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34103/01/2010
Labeler - Time-Cap Labs, Inc (037052099)
Registrant - Time-Cap Labs, Inc (037052099)
Establishment
NameAddressID/FEIOperations
Time-Cap Labs, Inc037052099manufacture

 
Time-Cap Labs, Inc

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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