Amerisource Bergen Allergy Capsules Drug Facts

Amerisource Bergen Allergy Capsules Drug Facts
SPL v1
SPL
SPL Set ID 3778db9b-ed94-4240-b045-d0d60f0ef9e9
Route
ORAL
Published
Effective Date 2009-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (25 mg)
Inactive Ingredients
Benzyl Alcohol Butylparaben D&c Red No. 28 D&c Yellow No. 10 Edetate Calcium Disodium Fd&c Blue No. 1 Fd&c Blue No. 2 Fd&c Red No. 40 Gelatin Lactose Magnesium Stearate Methylparaben Polysorbate 80 Propylparaben Silicon Dioxide Sodium Lauryl Sulfate Sodium Propionate

Identifiers & Packaging

Pill Appearance
Imprint: L462 Shape: capsule Color: pink Color: white Color: red Size: 14 mm Score: 1
Marketing Status
OTC MONOGRAPH FINAL Active Since 1989-10-15

Description

Diphenhydramine hydrochloride 25 mg

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Diphenhydramine hydrochloride 25 mg

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat
  • temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing
Directions
  • take every 4 to 6 hours, not more than 6 doses in 24 hours
adults and children 12 years of age and over 1 or 2 capsules
children 6 to under 12 years of age 1 capsule
children 4 to under 6 years of age do not use unless directed by a doctor
children under 4 years of age do not use
Do Not Use
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Other Information
  • store at room temperature (59°-86°F)
  • protect from moisture
Inactive Ingredients

benzyl alcohol, butylparaben, D&C red no. 28, D&C yellow no. 10, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C blue no. 2, FD&C red no. 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide, sodium lauryl sulfate, sodium propionate

Questions Or Comments?

1-800-719-9260

Principal Display Panel

Compare to active ingredient in Benadryl® Allergy Kapseals®

See New Warning and Dosing Directions

Allergy

Diphenhydramine HCl

Antihistamine

Easy to Swallow

For Allergy Relief

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

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 driving a motor vehicle or operating machinery
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.

Active Ingredient (in Each Capsule)

Diphenhydramine hydrochloride 25 mg

Ask A Doctor Before Use If You Have
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are

taking tranquilizers or sedatives


Structured Label Content

Uses
  • temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:
  • runny nose
  • sneezing
  • itchy, watery eyes
  • itchy nose or throat
  • temporarily relieves these symptoms of the common cold:
  • runny nose
  • sneezing
Purpose

Antihistamine

Directions
  • take every 4 to 6 hours, not more than 6 doses in 24 hours
adults and children 12 years of age and over 1 or 2 capsules
children 6 to under 12 years of age 1 capsule
children 4 to under 6 years of age do not use unless directed by a doctor
children under 4 years of age do not use
Do Not Use (Do not use)
  • with any other product containing diphenhydramine, even one used on skin
  • to make a child sleepy
Other Information (Other information)
  • store at room temperature (59°-86°F)
  • protect from moisture
Inactive Ingredients (Inactive ingredients)

benzyl alcohol, butylparaben, D&C red no. 28, D&C yellow no. 10, edetate calcium disodium, edible ink, FD&C blue no. 1, FD&C blue no. 2, FD&C red no. 40, gelatin, lactose, magnesium stearate, methylparaben, polysorbate 80, propylparaben, silicon dioxide, sodium lauryl sulfate, sodium propionate

Questions Or Comments? (Questions or comments?)

1-800-719-9260

Principal Display Panel

Compare to active ingredient in Benadryl® Allergy Kapseals®

See New Warning and Dosing Directions

Allergy

Diphenhydramine HCl

Antihistamine

Easy to Swallow

For Allergy Relief

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

When Using This Product (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 driving a motor vehicle or operating machinery
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

In case of overdose, get medical help or contact a Poison Control Center right away.

Active Ingredient (in Each Capsule) (Active ingredient (in each capsule))

Diphenhydramine hydrochloride 25 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • trouble urinating due to an enlarged prostate gland
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

taking tranquilizers or sedatives


Advanced Ingredient Data


Raw Label Data

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