SPL v4
SPL
SPL Set ID 77a5f0d0-18cf-4618-85b7-90c86a1f2e23
Route
ORAL
Published
Effective Date 2019-09-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 1) Dextromethorphan (15 1) Guaifenesin (200 1) Phenylephrine (5 1)
Inactive Ingredients
Starch, Corn Cellulose, Microcrystalline Povidone Sodium Starch Glycolate Type A Corn Stearic Acid Maltodextrin Silicon Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2016-10-25

Description

Active Ingredients (In Each Tablet) Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg


Medication Information

Warnings and Precautions

Warnings:

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, if you take with other drugs containing acetaminophen (prescription or nonprescription), or if you have 3 or more alcoholic drinks every day while using this product.

Indications and Usage

Uses: For temporary relief of:

• cough • sore throat • minor aches • pain

• headaches • nasal congestion • fever

• helps loosen phlegm (mucus), thin bronchial secretions to make coughs more productive

Dosage and Administration

Directions: Do not use more than directed.

Adults and children: (12 years and older) Take 2 tablets with water every 6-8 hours as needed. Do not take more than 8 tablets in 24 hours, or as directed by doctor.

Children: (under 12 years) Do use unless directed by a doctor.

Description

Active Ingredients (In Each Tablet) Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg

Section 34088-5

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1

KEEP OUT OF REACH OF CHILDREN.

Section 50566-9

Stop use and ask a doctor if: you get nervous, dizzy or sleepless, cough lasts more than 7 days, comes back or occurs with fever, rash or headache that lasts. These could be signsof a serious condition.

Section 50569-3

Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, cough that occurs with too much phlegm (mucus), chronic cough that lasts such as occurs with smoking, asthma, or emphysema or chronic bronchitis.

Section 51727-6

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

Section 51945-4

res

Section 53414-9

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

Section 55105-1

Pain reliever/fever reducer, Cough suppressant, Expectorant, Nasal decongestant

Section 55106-9

Active Ingredients (In Each Tablet)

Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg


Structured Label Content

Indications and Usage (34067-9)

Uses: For temporary relief of:

• cough • sore throat • minor aches • pain

• headaches • nasal congestion • fever

• helps loosen phlegm (mucus), thin bronchial secretions to make coughs more productive

Dosage and Administration (34068-7)

Directions: Do not use more than directed.

Adults and children: (12 years and older) Take 2 tablets with water every 6-8 hours as needed. Do not take more than 8 tablets in 24 hours, or as directed by doctor.

Children: (under 12 years) Do use unless directed by a doctor.

Warnings and Precautions (34071-1)

Warnings:

Liver Warning:

This product contains acetaminophen. Severe liver damage may occur if you take more than 8 tablets in 24 hours, if you take with other drugs containing acetaminophen (prescription or nonprescription), or if you have 3 or more alcoholic drinks every day while using this product.

Section 34088-5 (34088-5)

In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Section 50565-1 (50565-1)

KEEP OUT OF REACH OF CHILDREN.

Section 50566-9 (50566-9)

Stop use and ask a doctor if: you get nervous, dizzy or sleepless, cough lasts more than 7 days, comes back or occurs with fever, rash or headache that lasts. These could be signsof a serious condition.

Section 50569-3 (50569-3)

Ask a doctor before use if you have: heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, cough that occurs with too much phlegm (mucus), chronic cough that lasts such as occurs with smoking, asthma, or emphysema or chronic bronchitis.

Section 51727-6 (51727-6)

SEE ORIGINAL BOX FOR COMPLETE PRODUCT INFORMATION

Section 51945-4 (51945-4)

res

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Pain reliever/fever reducer, Cough suppressant, Expectorant, Nasal decongestant

Section 55106-9 (55106-9)

Active Ingredients (In Each Tablet)

Acetaminophen 325 mg, Dextromethorphan HBr 15 mg, Guaifenesin 200 mg, Phenylephrine HCl 5 mg


Advanced Ingredient Data


Raw Label Data

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