Cough
FDA Label NDC 21695-705

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rebel Distributors Corp for the product Cough (NDC 21695-705). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient (in each 5 ml teaspoonful), uses, ask a doctor before use if you have, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient (In Each 5 Ml Teaspoonful)

Guaifenesin 100 mg

Uses

helps loosen phlegm and thin bronchial secretions to rid the bronchial passageways of bothersome mucus

Ask A Doctor Before Use If You Have

  • a cough with too much phlegm (mucus)
  • a persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Otc - Stop Use

Stop use and ask a doctor if cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.

Otc - Pregnancy Or Breast Feeding

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

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

  • take every four hours
  • do not take more than 6 doses in 24 hours
    • adults and children 12 years and over2–4 teaspoonfuls
    children 6 to under 12 years1–2 teaspoonfuls
    children under 6 yearsdo not use

Other Information

  • each teaspoonful contains: sodium 3 mg
  • store at room temperature 15°–30°C (59°–86°F)

Inactive Ingredients

caramel powder, citric acid, corn syrup, FD&C red #40, glycerin, menthol, propylene glycol, purified water, saccharin sodium, sodium benzoate

Otc - Questions

1-800-645-2158, 9 am – 5 pm ET, Monday – Friday

Tamper Evident

DO NOT USE IF INNER FOIL SEAL OVER MOUTH OF BOTTLE IS BROKEN OR MISSING

Principal Display Panel - 118 Ml Bottle Label

Rebel Distributors Corp
NDC 21695-705-04

  • FOR ADULTS AND CHILDREN
  • NON-NARCOTIC EXPECTORANT
  • ALCOHOL FREE

    • Cough
    SYRUP
    Guaifenesin, USP

    4 fl oz (118 mL)

    Guaifenesin 100mg/5ml (5379a585 584d 45f5 9113 Dffc277d5876 01)

    Guaifenesin 100mg/5ml (5379a585 584d 45f5 9113 Dffc277d5876 01)

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