ALLERGY- diphenhydramine hydrochloride capsule 
Kroger Company

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.

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Kroger Co. Allergy Capsules 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

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

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

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
  • do not take more than 6 doses in 24 hours
adults and children 12 years and over1 to 2 capsules
children 6 to under 12 years1 capsule
children under 6 years do not use this product in children under 6 years of age

Inactive ingredients

anhydrous lactose, benzyl alcohol, butylparaben, D&C red no. 28, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C red no. 40, gelatin, magnesium stearate, methylparaben, polysorbate 80, propylparaben, sodium lauryl sulfate, sodium propionate

Questions or comments?

1-800-632-6900

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Allergy Capsules

Antihistamine

Easy to Swallow

Diphenhydramine HCl 25 mg

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat due to Allergies and Colds

Actual Size

25 mg EACH

Allergy Capsules Carton Image 1

Allergy Capsules Carton Image 1

Allergy Capsules Carton Image 2

Allergy Capsules Carton Image 2

ALLERGY 
diphenhydramine hydrochloride capsule
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:30142-462
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (DIPHENHYDRAMINE) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
BENZYL ALCOHOL 
BUTYLPARABEN 
D&C RED NO. 28 
EDETATE CALCIUM DISODIUM 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
GELATIN 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYSORBATE 80 
PROPYLPARABEN 
SODIUM LAURYL SULFATE 
SODIUM PROPIONATE 
Product Characteristics
ColorPINK (clear) , WHITE (clear) , RED (band) Scoreno score
ShapeCAPSULESize14mm
FlavorImprint Code L462
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:30142-462-622 in 1 CARTON
112 in 1 BLISTER PACK
2NDC:30142-462-674 in 1 CARTON
212 in 1 BLISTER PACK
3NDC:30142-462-781 in 1 CARTON
3100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34108/15/1990
Labeler - Kroger Company (006999528)

Revised: 4/2012
Document Id: dec96758-35dc-4cd5-9324-79776756e76c
Set id: dec96758-35dc-4cd5-9324-79776756e76c
Version: 1
Effective Time: 20120412
 
Kroger Company