ALLER-G-TIME

Dosage form: tablet, film coated
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: TIME CAP LABORATORIES, INC
NDC Code: 49483-061

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 INGREDIENTS:

In each tablet : DIPHENHYDRAMINE HCL

 

PURPOSE:  ANTIHISTAMINE

Keep Out of the Reach of Children:   In case of overdose, get medical help or contact a Poison Control Center right away

INDICATIONS AND USAGE:

TEMPORARILY RELIEFSTHESE SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER RESPIRATORY ALLERGIES:

RUNNING NOSE, ITCHY, WATERY EYES, SNEEZING, ITCHY NOSE OR THROAT

TEMPORARILY RELIEVES THESE SYMPTOMS DUE TO THE COMMON COLD:  RUNNY NOSE, SNEEZING

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

Directions - take every 4 t0 6 hours.
Do not take more than 6 doses in 24 hours.
adults and children 12 years of age and older - 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, d-c red no 27 aluminum lke, dibasic calcium phosphate dehydrate, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol-PEG-400, polysorbate80, titanium dioxide.



ALLER-G-TIME 
diphenhydramine hydrochloride tablet, film coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49483-061
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM  
D&C RED NO. 27 
DIBASIC CALCIUM PHOSPHATE DIHYDRATE 
HYPROMELLOSES 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 400 
POLYSORBATE 80 
TITANIUM DIOXIDE 
Product Characteristics
ColorpinkScoreno score
ShapeCAPSULESize11mm
FlavorImprint CodeT061
Contains    
Packaging
#Item CodePackage Description
1NDC:49483-061-01100 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
2NDC:49483-061-101000 TABLET, FILM COATED (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34105/01/2012
Labeler - TIME CAP LABORATORIES, INC (037052099)
Establishment
NameAddressID/FEIOperations
TIME CAP LABORATORIES, INC037052099manufacture

Revised: 05/2012
 
TIME CAP LABORATORIES, INC

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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