Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID e7cf7c5d-5c9a-4201-9e30-1cd616071855
Route
ORAL
Published
Effective Date 2024-01-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Dextromethorphan (15 mg) Doxylamine (6.25 mg)
Inactive Ingredients
D&c Yellow No. 10 Fd&c Blue No. 1 Gelatin, Unspecified Glycerin Mineral Oil Polyethylene Glycol, Unspecified Povidone, Unspecified Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: R Shape: oval Color: green Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-07-01

Description

Acetaminophen, USP 325 mg Dextromethorphan HBr, USP 15 mg Doxylamine Succinate, USP 6.25 mg

Purpose

Pain reliever/Fever reducer Cough suppressant Antihistamine


Medication Information

Warnings and Precautions

Warnings

Indications and Usage

Uses

  • temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:
    • headache
    • sore throat
    • cough
    • minor aches and pains
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily reduces fever
Purpose

Pain reliever/Fever reducer Cough suppressant Antihistamine

Dosage and Administration

Directions

  • do not take more than 8 capsules in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • this adult product is not intended for use in children under 12 years of age
age dose

adults and children 12 years and over

2 capsules every 6 hours

children under 12 years

do not use

Description

Acetaminophen, USP 325 mg Dextromethorphan HBr, USP 15 mg Doxylamine Succinate, USP 6.25 mg

Section 42229-5

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

Section 44425-7

Other information

  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
Section 50565-1

Keep out of reach of children.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 51727-6

Inactive ingredients

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Section 53413-1

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1 800-762-4675

Section 53414-9

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

Purposes

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

Do Not Use
  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Liver Warning

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

  • more than 8 capsules in any 24-hour period, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Sore Throat Warning

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

Principal Display Panel

ADULT

Robitussin ®

  • MAXIMUM

    STRENGTH
  • SEVERE

    Multi-Symptom

    7 in 1 Relief

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

CF

NIGHTTIME

MAX

  • Cough, Sore Throat
  • Body Aches, Fever
  • Runny Nose, Sneezing
  • Itchy Throat

For Ages 12 & Over

10

LIQUID-FILLED

CAPSULES

When Using This Product
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.
  • new symptoms occur
Ask A Doctor Before Use If You Have
  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer
  • taking sedatives or tranquilizers
Active Ingredients (in Each Liquid Filled Capsule)

Acetaminophen, USP 325 mg

Dextromethorphan HBr, USP 15 mg

Doxylamine Succinate, USP 6.25 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves these symptoms occurring with a cold or flu, hay fever, or other upper respiratory allergies:
    • headache
    • sore throat
    • cough
    • minor aches and pains
    • runny nose
    • sneezing
    • itchy, watery eyes
    • itching of the nose or throat
  • temporarily reduces fever
Dosage and Administration (34068-7)

Directions

  • do not take more than 8 capsules in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommended dose (overdose) may cause serious liver damage.
  • this adult product is not intended for use in children under 12 years of age
age dose

adults and children 12 years and over

2 capsules every 6 hours

children under 12 years

do not use

Warnings and Precautions (34071-1)

Warnings

Section 42229-5 (42229-5)

Allergy alert:acetaminophen may cause severe skin reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash

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

Section 44425-7 (44425-7)

Other information

  • store at 20-25°C (68-77°F). Avoid excessive heat above 40°C (104°F).
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. Prompt 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

D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, mineral oil, pharmaceutical ink, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution

Section 53413-1 (53413-1)

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1 800-762-4675

Section 53414-9 (53414-9)

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

Purposes

Pain reliever/Fever reducer

Cough suppressant

Antihistamine

Do Not Use (Do not use)
  • to sedate a child or to make a child sleepy
  • if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
Liver Warning (Liver warning)

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

  • more than 8 capsules in any 24-hour period, which is the maximum daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product
Sore Throat Warning (Sore throat warning)

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

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

ADULT

Robitussin ®

  • MAXIMUM

    STRENGTH
  • SEVERE

    Multi-Symptom

    7 in 1 Relief

ACETAMINOPHEN (Pain Reliever/Fever Reducer)

DEXTROMETHORPHAN HBr (Cough Suppressant)

DOXYLAMINE SUCCINATE (Antihistamine)

CF

NIGHTTIME

MAX

  • Cough, Sore Throat
  • Body Aches, Fever
  • Runny Nose, Sneezing
  • Itchy Throat

For Ages 12 & Over

10

LIQUID-FILLED

CAPSULES

When Using This Product (When using this product)
  • marked drowsiness may occur
  • avoid alcoholic drinks
  • alcohol, sedatives, and tranquilizers may increase drowsiness
  • be careful when driving a motor vehicle or operating machinery
  • excitability may occur, especially in children
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts.

    These could be signs of a serious condition.
  • new symptoms occur
Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • glaucoma
  • trouble urinating due to an enlarged prostate gland
  • cough that occurs with too much phlegm (mucus)
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis, or emphysema
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking any other pain reliever/fever reducer
  • taking sedatives or tranquilizers
Active Ingredients (in Each Liquid Filled Capsule) (Active ingredients (in each liquid-filled capsule))

Acetaminophen, USP 325 mg

Dextromethorphan HBr, USP 15 mg

Doxylamine Succinate, USP 6.25 mg


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