Walgreens Ndcs

Walgreens Ndcs
SPL v3
SPL
SPL Set ID 02e5f475-4e9f-2856-e063-6294a90a21fd
Route
ORAL
Published
Effective Date 2024-02-13
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (0.03 g) Dextromethorphan (0.65 g) Doxylamine (0.0125 g)
Inactive Ingredients
Glycerin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-02-13

Description

Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use


Medication Information

Warnings and Precautions

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4 doses in 24 hrs, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

skin reddening

blisters

rash

If skin reaction occurs, stop use and seek medical help right away

Sore throat warning: If sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Indications and Usage

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat & bronchial irritation

sore throat

headache

minor aches & pains

fever

runny nose and sneezing

Dosage and Administration

Directions

take only as directed

only use the dose cup provided

do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Description

Directions take only as directed only use the dose cup provided do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use

Section 50565-1

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Section 51727-6

Inactive ingredients alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No.1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose

Section 51945-4

Section 55105-1

Active Ingredients (in each 30 mL) Purpose

Acetaminophen 650 mg……………………………………………………………………………………………………………….……….. Pain reliever/fever reducer

Dextromethorphan HBr 30 mg…………………………………………………………………………………………………….….………….……. Cough suppressant

Doxylamine succinate 12.5 mg………………………………………………………………………………………………………………………….……. Antihistamine


Structured Label Content

Indications and Usage (34067-9)

Uses

temporarily relieves common cold/flu symptoms:

cough due to minor throat & bronchial irritation

sore throat

headache

minor aches & pains

fever

runny nose and sneezing

Dosage and Administration (34068-7)

Directions

take only as directed

only use the dose cup provided

do not exceed 4 doses per 24 hrs

adults & children 12 yrs & over

30 mL every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

Warnings and Precautions (34071-1)

Warnings

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take

more than 4 doses in 24 hrs, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Allergy Alert: Acetaminophen may cause severe skin reactions.

Symptoms may include:

skin reddening

blisters

rash

If skin reaction occurs, stop use and seek medical help right away

Sore throat warning: If sore throat is severe, persist for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Section 50565-1 (50565-1)

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

Section 51727-6 (51727-6)

Inactive ingredients alcohol, citric acid, D&C Yellow No. 10, FD&C Blue No.1, flavor, glycerin, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, sucralose

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Active Ingredients (in each 30 mL) Purpose

Acetaminophen 650 mg……………………………………………………………………………………………………………….……….. Pain reliever/fever reducer

Dextromethorphan HBr 30 mg…………………………………………………………………………………………………….….………….……. Cough suppressant

Doxylamine succinate 12.5 mg………………………………………………………………………………………………………………………….……. Antihistamine


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