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Allergy Relief by Mckesson (Sunmark)

Medically reviewed on August 30, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Mckesson (Sunmark)
NDC Code: 49348-971

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 (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses

temporarily relieves these symptoms of the common cold:

  • runny nose
  • sneezing 

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

  • runny nose
  • sneezing
  • itching of the nose or throat
  • itchy, watery eyes

Warnings

Do not use
  • 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
  • excitability may occur, especially in children
  • marked drowsiness may occur

  • avoid alcoholic drinks

  • alcohol, sedatives, and tranquilizers may increase drowsiness

  • be careful when operating machinery or driving a motor vehicle

If pregnant of breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away: 1-800-222-1222

Directions
  • take every 4 to 6 hours, not more than 6 doses in 24 hours
 adults and children 12 years of age and over take 1 or 2 capsules 
 children 6 to under 12 years of age take 1 capsule
children under 6 years of ageconsult a doctor
 children under 4 years of age do not use

Other information
  • store at controlled room temperature 15°-30°C (59°-86°F) in a dry place
  • protect from light

  • do not use if imprinted safety seal under cap is broken or missing
  • do not use if red band around capsule is broken or missing

Inactive ingredients

D&C red #28, edible ink, FD&C blue #1, FD&C red #40, gelatin, lactose and starch.

Questions or comments?

Call toll free 1-877-753-3935

Principal Display Panel

Allergy Relief

Antihistamine

For the temporary relief of:

sneezing, itchy & watery eyes, runny nose & itchy throat

Diphenhydramine HCl 25 mg

Compare to Benadryl® Kapgels® Active Ingredient*

*This product is not manufactured or distributed by McNeil Consumer Healthcare, Division of McNeil-PPC, Inc., owner of the registered trademark Benadryl® Allergy Kapgels®

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

Product Label

Diphenhydramine HCl 25 mg

ALLERGY RELIEF 
diphenhydramine hcl capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-971
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
STARCH, CORN 
Product Characteristics
ColorPINK (and white) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint CodeCPC835
Contains    
Packaging
#Item CodePackage Description
1NDC:49348-971-101 BOTTLE (1 BOTTLE) in 1 BOX
1100 CAPSULE (100 CAPSULE) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart33608/26/2011
Labeler - Mckesson (Sunmark) (177667227)

 
Mckesson (Sunmark)

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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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