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Allergy by Allegiant Health

Medically reviewed on Dec 15, 2017

Dosage form: tablet
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Allegiant Health
NDC Code: 69168-048

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 ingredient

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

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

Warnings

Do not usewith any other products containing diphenhydramine, including one applied topically

Ask a doctor if you have

a breathing problem such as emphysema or chronic bronchitis, glaucoma or 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 beverages alcohol, sedatives, and tranquilizers may increase drowsiness be careful when drivinga 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

In case of accidental overdose, contact a doctor or Poison Control Center immediately

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 older: 25 mg to 50 mg (1 to 2 caplets)
Children 6 to under 12 years of age (See ** symbol below): 12.5 mg** to 25 mg (1 caplet)
Children under 6 years of age: Consult a doctor
** A 12.5 mg dosage strength is not available in this package. (Do not attempt to break caplet)

Inactive Ingredients

croscarmellose sodium, D.&C. Red #27, hydroxypropylmethyl cellulose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, titanium dioxide

Package/Label Principal Display Panel
ALLERGY 
diphenhydramine hcl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-048
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
CROSCARMELLOSE SODIUM 
D&C RED NO. 27 
HYPROMELLOSES 
LACTOSE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOLS 
SILICON DIOXIDE 
TITANIUM DIOXIDE 
Product Characteristics
ColorPINKScoreno score
ShapeCAPSULESize12mm
FlavorImprint CodeAZ048
Contains    
Packaging
#Item CodePackage Description
1NDC:69168-048-9324 TABLET in 1 BOX
2NDC:69168-048-01100 TABLET in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34112/15/2014
Labeler - Allegiant Health (079501930)
Registrant - Allegiant Health (079501930)
Establishment
NameAddressID/FEIOperations
Allegiant Health079501930ANALYSIS(69168-048), LABEL(69168-048), MANUFACTURE(69168-048), PACK(69168-048), RELABEL(69168-048), REPACK(69168-048)

 
Allegiant Health

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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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