DailyMed - DailyMed Details

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Citric Acid Monohydrate D&c Red No. 33 Fd&c Red No. 40 Glycerin Poloxamer 407 Water Sodium Benzoate Sodium Chloride Sodium Citrate Sucrose

Identifiers & Packaging

Pill Appearance

Color: pink

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-09-30

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

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 (12.5 mg to 25 mg)

Description

Drug Facts Active ingredient (in each 5 mL teaspoon) 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.

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 tranquilizers

Section 50569-3

Ask a doctor before use if the child has

■ glaucoma

■ abreathing problem such as chronic bronchitis

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 or comments? 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 ingredient

(in each 5 mL teaspoon)

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° - 25° C(68° - 77° F)

■ dosage cup provided

Product Label

AP SAFE NDC 72681-505-24

COMPARE TO THE

ACTIVE INGREDIENT IN

CHILDREN'S BENADRYL ^®

ALLERGY LIQUID*

Children's

Allergy

Relief

DIPHENHYDRAMINE HCl

Liquid

Antihistamine

Relieves: Sneezing,

Runny Nose,

Itchy Watery Eyes,

Itchy Throat

• Alcohol-Free

4 FL OZ (118 mL) Cherry Flavor

DO NOT USE IF PRINTED SEAL

UNDER CAP IS TORN OR MISSING

2

1013430

3/20

*This product is not manufactured or

distributed by McNeil PPC, Inc., distributor

of Benadryl ^®Allergy liquid.

Manufactured by:

AptaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

AP-BX-03

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 (12.5 mg to 25 mg)

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

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.

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 tranquilizers

Section 50569-3 (50569-3)

Ask a doctor before use if the child has

■ glaucoma

■ abreathing problem such as chronic bronchitis

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 or comments? 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 ingredient

(in each 5 mL teaspoon)

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° - 25° C(68° - 77° F)

■ dosage cup provided

Product Label

AP SAFE NDC 72681-505-24

COMPARE TO THE

ACTIVE INGREDIENT IN

CHILDREN'S BENADRYL ^®

ALLERGY LIQUID*

Children's

Allergy

Relief

DIPHENHYDRAMINE HCl

Liquid

Antihistamine

Relieves: Sneezing,

Runny Nose,

Itchy Watery Eyes,

Itchy Throat

• Alcohol-Free

4 FL OZ (118 mL) Cherry Flavor

DO NOT USE IF PRINTED SEAL

UNDER CAP IS TORN OR MISSING

2

1013430

3/20

*This product is not manufactured or

distributed by McNeil PPC, Inc., distributor

of Benadryl ^®Allergy liquid.

Manufactured by:

AptaPharma Inc.,

1533 Union Ave.

Pennsauken, NJ 08110

AP-BX-03

Carton

Bottle

res

Advanced Ingredient Data

[{"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "D&C RED NO. 33", "unii": "9DBA0SBB0L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "GLYCERIN", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLOXAMER 407", "unii": "TUF2IVW3M2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CHLORIDE", "unii": "451W47IQ8X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCROSE", "unii": "C151H8M554", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}]

Raw Label Data

All Sections (JSON)

{"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", "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 (12.5 mg to 25 mg)", "34071-1": "Warnings Do not use ■ with any other product containing diphenhydramine, even one used on skin ■ to make a child sleepy", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.", "50567-7": "When using this product ■ marked drowsiness may occur ■ excitability may occur, especially in children ■ sedatives and tranquilizers may increase drowsiness", "50568-5": "Ask a doctor or pharmacist before use if the child is taking sedatives or tranquilizers", "50569-3": "Ask a doctor before use if the child has ■ glaucoma ■ abreathing problem such as chronic bronchitis", "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", "53413-1": "Questions or comments? Call weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944.", "55105-1": "Purpose Antihistamine", "55106-9": "Drug Facts Active ingredient (in each 5 mL teaspoon) Diphenhydramine HCL 12.5 mg", "60561-8": "Other Information ■ Keep carton for full directions for use ■ each teaspoonful contains: sodium 10 mg ■ store at 20° - 25° C(68° - 77° F) ■ dosage cup provided", "Product Label": "AP SAFE NDC 72681-505-24 COMPARE TO THE ACTIVE INGREDIENT IN CHILDREN'S BENADRYL ® ALLERGY LIQUID* Children's Allergy Relief DIPHENHYDRAMINE HCl Liquid Antihistamine Relieves: Sneezing, Runny Nose, Itchy Watery Eyes, Itchy Throat • Alcohol-Free 4 FL OZ (118 mL) Cherry Flavor DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING 2 1013430 3/20 *This product is not manufactured or distributed by McNeil PPC, Inc., distributor of Benadryl ® Allergy liquid. Manufactured by: AptaPharma Inc., 1533 Union Ave. Pennsauken, NJ 08110 AP-BX-03 Carton Bottle res"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information