Best Choice​®

Best Choice​®
SPL v1
SPL
SPL Set ID 0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d
Route
ORAL
Published
Effective Date 2025-01-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Diphenhydramine (12.5 mg)
Inactive Ingredients
Citric Acid D&c Red No. 33 Fd&c Red No. 40 Glycerin Poloxamer 407 Water Sodium Benzoate Sodium Chloride Sodium Citrate Sucrose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-01-01

Description

Drug Facts Active ingredients (in each 5 mL teaspoonful) Diphenhydramine HCl 12.5 mg


Medication Information

Warnings and Precautions

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 the child has

■ glaucoma

■ a breathing problem such as chronic bronchitis

Indications and Usage

Uses

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

      ■ sneezing

      ■ itching of the nose or throat

      ■ runny nose

      ■ itchy watery eyes

■temporarily relieves these symptoms due to the common cold:

      ■ sneezing

      ■ runny nose

Dosage and Administration

Directions

■ if needed, take every 4-6 hours

■ do not take more than 6 doses in 24-hours

 children under 4 years of age  Do not use
 children 4 to under 6 years of age  Do not use unless directed by a

 doctor
 children 6 to under 12 years of age  1 to 2 teaspoonfuls

(5 ml to 10 ml)

Description

Drug Facts Active ingredients (in each 5 mL teaspoonful) Diphenhydramine HCl 12.5 mg

Section 50565-1

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)

Section 50567-7

When using this product

■ marked drowsiness may occur

■ excitability may occur, especially in children

■ sedatives and tranquilizers may increase drowsiness

Section 50568-5

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquillizers

Section 51727-6

Inactive ingredients

citric acid, D&C red # 33, FD&C Red #40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium

chloride, sodium citrate, sucrose

Section 53413-1

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Section 55105-1

Purpose

Antihistamine

Section 55106-9

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)



Diphenhydramine HCl 12.5 mg

Section 60561-8

Other information

Keep carton for full directions for use

Each teaspoonful contains: sodium 10 mg

■ store at 20 - 25º C (68 - 77" F)

■ dosage cup provided

Product Label: Best Choice® Children's Allergy Relief

Best Choice®

Children's Allergy Relief

Diphenhydramine HCl

Oral Solution

Antihistamine

Cherry Flavor

8 FL OZ (237 mL)

* This product is not manufactured or distributed by McNeil PPC, Inc., distributor of Benadryl® Allergy Liquid.

PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO.

5000 KANSAS AVE, KANSAS CITY, KS 66106

Carton

Bottle

res


Structured Label Content

Indications and Usage (34067-9)

Uses

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

      ■ sneezing

      ■ itching of the nose or throat

      ■ runny nose

      ■ itchy watery eyes

■temporarily relieves these symptoms due to the common cold:

      ■ sneezing

      ■ runny nose

Dosage and Administration (34068-7)

Directions

■ if needed, take every 4-6 hours

■ do not take more than 6 doses in 24-hours

 children under 4 years of age  Do not use
 children 4 to under 6 years of age  Do not use unless directed by a

 doctor
 children 6 to under 12 years of age  1 to 2 teaspoonfuls

(5 ml to 10 ml)

Warnings and Precautions (34071-1)

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 the child has

■ glaucoma

■ a breathing problem such as chronic bronchitis

Section 50565-1 (50565-1)

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)

Section 50567-7 (50567-7)

When using this product

■ marked drowsiness may occur

■ excitability may occur, especially in children

■ sedatives and tranquilizers may increase drowsiness

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if the child is taking sedatives or tranquillizers

Section 51727-6 (51727-6)

Inactive ingredients

citric acid, D&C red # 33, FD&C Red #40, flavor, glycerin, poloxamer 407, purified water, sodium benzoate, sodium

chloride, sodium citrate, sucrose

Section 53413-1 (53413-1)

Questions? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944

Section 55105-1 (55105-1)

Purpose

Antihistamine

Section 55106-9 (55106-9)

Drug Facts

Active ingredients

(in each 5 mL teaspoonful)



Diphenhydramine HCl 12.5 mg

Section 60561-8 (60561-8)

Other information

Keep carton for full directions for use

Each teaspoonful contains: sodium 10 mg

■ store at 20 - 25º C (68 - 77" F)

■ dosage cup provided

(-----------)

Product Label: Best Choice® Children's Allergy Relief

Best Choice®

Children's Allergy Relief

Diphenhydramine HCl

Oral Solution

Antihistamine

Cherry Flavor

8 FL OZ (237 mL)

* This product is not manufactured or distributed by McNeil PPC, Inc., distributor of Benadryl® Allergy Liquid.

PROUDLY DISTRIBUTED BY: VALU MERCHANDISERS, CO.

5000 KANSAS AVE, KANSAS CITY, KS 66106

Carton

Bottle

res


Advanced Ingredient Data


Raw Label Data

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