Allergy Relief

Drug Facts

Composition & Product

Active Ingredients

Diphenhydramine (12.5 mg)

Inactive Ingredients

Citric Acid Monohydrate Fd&c Red No. 40 Glycerin Methylparaben Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sorbitol Sucralose

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH FINAL Active Since 2020-03-02

Medication Information

Purpose

Antihistamine

Description

Diphenhydramine HCL, 12.5 mg

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

Section 42229-5

Compare to the active ingredient of Benadryl^®Allergy Liquid*

Relieves:

√ Runny Nose

√ Sneezing

√ Itchy, Watery Eyes

√ Itchy Throat

Cherry Flavor

Alcohol Free

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl ^® Allergy.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to the enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product:

• excitability might occur, especially in children

• marked drowsiness may occur • avoid alcoholic drinks

• alcohol, sedatives, and tranquilizers may increase drowsiness effect

• be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

• Take every 4 to 6 hours, or as directed by doctor.

• Do not exceed recommended dose.

Adults and Children 12 years of age and over:	take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours
Children 6 to under 12 years of age:	take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours
Children under 6 years of age:	consult a doctor

Drug Facts

Other Information

• Store at controlled room temperature 15°-30°C (59°-86°F).

• Do not refrigerate. Avoid excessive heat or humidity.

• Protect from light.

Inactive Ingredients

Cherry flavor, citric acid, FD&C Red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, and sucralose

Questions Or Comments?

Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072 | www.kramernovis.com

Manufactured in the USA for Kramer Novis, San Juan, PR 00917

Active Ingredient (in Each 5 Ml Tsp)

Diphenhydramine HCL, 12.5 mg

Structured Label Content

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

Section 42229-5 (42229-5)

Compare to the active ingredient of Benadryl^®Allergy Liquid*

Relieves:

√ Runny Nose

√ Sneezing

√ Itchy, Watery Eyes

√ Itchy Throat

Cherry Flavor

Alcohol Free

*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl ^® Allergy.

TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Purpose

Antihistamine

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

• a breathing problem such as emphysema or chronic bronchitis

• glaucoma

• trouble urinating due to the enlarged prostate gland

Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers.

When using this product:

• excitability might occur, especially in children

• marked drowsiness may occur • avoid alcoholic drinks

• alcohol, sedatives, and tranquilizers may increase drowsiness effect

• be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding, ask a health professional before use.

Packaging

Directions

• Take every 4 to 6 hours, or as directed by doctor.

• Do not exceed recommended dose.

Adults and Children 12 years of age and over:	take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours
Children 6 to under 12 years of age:	take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours
Children under 6 years of age:	consult a doctor

Drug Facts

Other Information (Other information)

• Store at controlled room temperature 15°-30°C (59°-86°F).

• Do not refrigerate. Avoid excessive heat or humidity.

• Protect from light.

Inactive Ingredients (Inactive ingredients)

Cherry flavor, citric acid, FD&C Red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, and sucralose

Questions Or Comments? (Questions or comments?)

Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072 | www.kramernovis.com

Manufactured in the USA for Kramer Novis, San Juan, PR 00917

Active Ingredient (in Each 5 Ml Tsp) (Active Ingredient (in each 5 mL tsp))

Diphenhydramine HCL, 12.5 mg

Advanced Ingredient Data

[{"name": "DIPHENHYDRAMINE", "unii": "8GTS82S83M", "classCode": "ACTIB", "strengthNumerator": "12.5", "strengthDenominator": "5", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "mL"}, {"name": "CITRIC ACID MONOHYDRATE", "unii": "2968PHW8QP", "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": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SORBITOL", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"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", "42229-5": "Compare to the active ingredient of Benadryl ® Allergy Liquid* Relieves: √ Runny Nose √ Sneezing √ Itchy, Watery Eyes √ Itchy Throat Cherry Flavor Alcohol Free *This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Benadryl ® Allergy. TAMPER EVIDENT: DO NOT USE IF SEAL UNDER CAP IS TORN, BROKEN OR MISSING.", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. ", "Purpose": "Antihistamine", "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 • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to the enlarged prostate gland Ask a doctor or pharmacist before use if you are taking sedatives or tranquilizers. When using this product: • excitability might occur, especially in children • marked drowsiness may occur • avoid alcoholic drinks • alcohol, sedatives, and tranquilizers may increase drowsiness effect • be careful when driving a motor vehicle or operating machinery If pregnant or breast-feeding, ask a health professional before use.", "Directions": "• Take every 4 to 6 hours, or as directed by doctor. • Do not exceed recommended dose. Adults and Children 12 years of age and over: take 10 to 20 mL (2 to 4 tsp) not to exceed 300 mg in 24 hours Children 6 to under 12 years of age: take 5 to 10 mL (1 to 2 tsp) not to exceed 150 mg in 24 hours Children under 6 years of age: consult a doctor", "Other information": "• Store at controlled room temperature 15°-30°C (59°-86°F). • Do not refrigerate. Avoid excessive heat or humidity. • Protect from light. ", "Inactive ingredients": "Cherry flavor, citric acid, FD&C Red #40, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sorbitol, and sucralose", "Questions or comments?": "Call weekdays from 8 AM to 4 PM AST at 1-787-767-2072 | www.kramernovis.com Manufactured in the USA for Kramer Novis, San Juan, PR 00917", "Active Ingredient (in each 5 mL tsp)": "Diphenhydramine HCL, 12.5 mg"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information