allergy relief

allergy relief
SPL v4
SPL
SPL Set ID 99ca3ec9-a28d-4851-951d-34aa982de9d8
Route
oral
Published
Effective Date 2022-11-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
diphenhydramine (25 mg)
Inactive Ingredients
silicon dioxide croscarmellose sodium dicalcium citrate d&c red no. 27 lecithin, soybean magnesium stearate microcrystalline cellulose polyethylene glycol, unspecified polyvinyl alcohol, unspecified talc titanium dioxide

Identifiers & Packaging

Pill Appearance
Imprint: S4 Shape: capsule Color: pink Size: 11 mm Score: 1
Marketing Status
otc monograph drug active Since 2022-11-14

Purpose

Antihistamine

Description

Diphenhydramine HCl 25 mg


Medication Information

Warnings

Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

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

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
 adults & children 12 years & over 1 to 2 tablets 
 children 6 to under 12 years 1 tablet
 children under 6 years do not use this product in children under 6 years of age

Other Information

• each tablet contains: calcium 24 mg • store between 15–30°C (59–86°F) • protect from moisture and light

Inactive Ingredients

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 27 Aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Description

Diphenhydramine HCl 25 mg

Drug Facts

Pouch Label

Compare to the active ingredient in: Benadryl® Allergy*

Diphenhydramine HCl 25 mg**

Relieves:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

**May cause drowsiness

Distributed By:

CABINET HEALTH P.B.C.

Active Ingredient



Diphenhydramine HCl 25 mg

Questions Or Comments?

1-888-333-9792

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)

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


Structured Label Content

Warnings

Do not use • to make a child sleepy • with any other product containing diphenhydramine, even one used on skin

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

Purpose

Antihistamine

Directions
  • take every 4 to 6 hours
  • do not take more than 6 doses in 24 hours
 adults & children 12 years & over 1 to 2 tablets 
 children 6 to under 12 years 1 tablet
 children under 6 years do not use this product in children under 6 years of age

Other Information (Other information)

• each tablet contains: calcium 24 mg • store between 15–30°C (59–86°F) • protect from moisture and light

Inactive Ingredients (Inactive ingredients)

Colloidal silicon dioxide, croscarmellose sodium, dicalcium phosphate, D&C Red No. 27 Aluminum lake, lecithin, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc, titanium dioxide

Drug Facts

Pouch Label

Compare to the active ingredient in: Benadryl® Allergy*

Diphenhydramine HCl 25 mg**

Relieves:

Sneezing

Itchy, Watery Eyes

Runny Nose

Itchy Throat

**May cause drowsiness

Distributed By: (Distributed by:)

CABINET HEALTH P.B.C.

Active Ingredient



Diphenhydramine HCl 25 mg

Questions Or Comments? (Questions or comments?)

1-888-333-9792

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. (1-800-222-1222)

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)

taking sedatives or tranquilizers


Advanced Ingredient Data


Raw Label Data

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