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  5. Label Information: Cough

FDA Label for Cough

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT (IN EACH 5 ML TEASPOONFUL)
    2. USES
    3. ASK A DOCTOR BEFORE USE IF YOU HAVE
    4. OTC - STOP USE
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - KEEP OUT OF REACH OF CHILDREN
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS
    10. OTC - QUESTIONS
    11. TAMPER EVIDENT
    12. PRINCIPAL DISPLAY PANEL - 118 ML BOTTLE LABEL

Cough Product Label

The following document was submitted to the FDA by the labeler of this product Rebel Distributors Corp. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

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