Gericare Tussincfmax 596

Gericare Tussincfmax 596
SPL v1
SPL
SPL Set ID 4744669c-7f33-e35f-e063-6394a90a79b7
Route
ORAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Dextromethorphan (20 mg) Guaifenesin (400 mg)
Inactive Ingredients
Hydroxyethyl Cellulose, Unspecified Sucralose Anhydrous Citric Acid Methylparaben Fd&c Red No. 40 Sodium Citrate Polyethylene Glycol, Unspecified Propylparaben Water Propylene Glycol Menthol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

Description

Active Ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg


Medication Information

Warnings and Precautions

Warnings

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

  • more than 6 doses 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

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

Do not use

  • 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 nonprescritpion), if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

  • liver disease
  • 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

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more tha 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headhache that lasts

These could be sign of a serious condition.

Indications and Usage

Uses

  • temporarily relieves these symptoms occurring with a cold or flu:
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tunes and make coughs more productive
Dosage and Administration

Directions

  • mL = mililiter
  • do not take more tha 6 doses in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommeded dose (overdose) may cause serious liver damage
  • measure only with dosing cup provided
  • keep dosing cup with product
  • adults and children 12 years and over: 20 mL every 4 hours
  • children under 12 years of age: do not use
Description

Active Ingredients (in each 20 mL) Acetaminophen 650 mg Dextromethorphan HBr 20 mg Guaifenesin 400 mg

Section 50565-1

Keep out of reach of children.

Section 51727-6

Inactive ingredients: artificial and natural flavor, citric acid, FD&C #40, hyroxyethyl cellulose, menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4

Section 53413-1

Questions or comments: 1-800-540-3765

Section 53414-9

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

Section 55105-1

Purpose

Pain reliever/fever reducer

Cough Suppressant

Expectorant

Section 55106-9

Active Ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg


Structured Label Content

Indications and Usage (34067-9)

Uses

  • temporarily relieves these symptoms occurring with a cold or flu:
  • cough due to minor throat and bronchial irritation
  • minor aches and pains
  • sore throat
  • headache
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tunes and make coughs more productive
Dosage and Administration (34068-7)

Directions

  • mL = mililiter
  • do not take more tha 6 doses in any 24-hour period
  • do not exceed recommended dosage. Taking more than the recommeded dose (overdose) may cause serious liver damage
  • measure only with dosing cup provided
  • keep dosing cup with product
  • adults and children 12 years and over: 20 mL every 4 hours
  • children under 12 years of age: 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 6 doses 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

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

Do not use

  • 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 nonprescritpion), if you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if you have

  • liver disease
  • 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

Stop use and ask a doctor if

  • pain or cough gets worse or lasts more than 7 days
  • fever gets worse or lasts more tha 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with rash or headhache that lasts

These could be sign of a serious condition.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

Inactive ingredients: artificial and natural flavor, citric acid, FD&C #40, hyroxyethyl cellulose, menthol, methylparaben, polyethylene glycol, propylene glycol, propylparaben, purified water, sodium citrate, sucralose

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)

Questions or comments: 1-800-540-3765

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)

Purpose

Pain reliever/fever reducer

Cough Suppressant

Expectorant

Section 55106-9 (55106-9)

Active Ingredients (in each 20 mL)

Acetaminophen 650 mg

Dextromethorphan HBr 20 mg

Guaifenesin 400 mg


Advanced Ingredient Data


Raw Label Data

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