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Allergy Relief by Freds, Inc.

Medically reviewed on Jan 19, 2017

Dosage form: capsule
Ingredients: DIPHENHYDRAMINE HYDROCHLORIDE 25mg
Labeler: Freds, Inc.
NDC Code: 55315-113

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.

FRD - 1113 - 2017-0119

Drug Facts

Active ingredient (in each capsule)

Diphenhydramine HCl 25 mg

Purpose

Antihistamine

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the 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
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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. 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, or as directed by a doctor
  • do not take more than 6 times in 24 hours
adults and children 12 years and over1 to 2 capsules
children 6 to under 12 years1 capsule
children under 6 yearsdo not use

Other information
  • store between 20-25°C (68-77°F)
  • retain carton for complete product information

Inactive ingredients

benzyl alcohol, butylparaben, D&C red #28, edible black ink, FD&C blue #1, FD&C red #40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate

PRINCIPAL DISPLAY PANEL

Fred's Pharmacy
NDC 55315-113-01
ALLERGY RELIEF
Diphenhydramine HCl 25 mg - Antihistamine
Relieves:
Sneezing
Runny Nose
Itchy, Watery Eyes
Itchy Nose or Throat
24 CAPSULES
Compare to the Active Ingredient in Benadryl® Allergy**

ALLERGY RELIEF 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55315-113
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL 
BUTYLPARABEN 
D&C RED NO. 28 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
Product Characteristics
Colorpink, whiteScoreno score
ShapeOVALSize14mm
FlavorImprint CodeA;20
Contains    
Packaging
#Item CodePackage Description
1NDC:55315-113-012 BLISTER PACK in 1 CARTON
112 CAPSULE in 1 BLISTER PACK
2NDC:55315-113-024 BLISTER PACK in 1 CARTON
212 CAPSULE in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34109/01/2008
Labeler - Freds, Inc. (005866116)

 
Freds, 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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