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  5. Label Information: Siltussin Sa

FDA Label for Siltussin Sa

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. OTC - ASK DOCTOR
    5. OTC - STOP USE
    6. OTC - PREGNANCY OR BREAST FEEDING
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. DIRECTIONS
    9. INACTIVE INGREDIENTS
    10. QUESTIONS
    11. OTHER

Siltussin Sa Product Label

The following document was submitted to the FDA by the labeler of this product Preferred Pharmaceuticals, Inc. 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.

Otc - Active Ingredient



Active Ingredient: Guaifenesin 100 mg (in each 5 mL (teaspoon)(TSP))


Otc - Purpose



Purpose: Expectorant


Indications & Usage



Uses Helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive


Otc - Ask Doctor



Ask a doctor before use if you have

  • •cough that occurs with too much phlegm (mucus)
  • •cough that lasts or is chronic such 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 is accompanied by fever, rash, or persistent headache. 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



  • •do not take more than 6 doses in any 24-hour period
  • •repeat dose every 4 hours

    • adults and children 12 years and over

    2-4 teaspoonfuls (TSP)

    children under 12 years

    DO NOT USE

    Other information

    Store at room temperature 20°-25°C (68°-77°F). Do not accept if imprinted tamper evident safety seal around cap is broken or missing.


Inactive Ingredients



citric acid, D&C yellow no. 10, FD&C blue no. 1, FD&C red no. 40, strawberry flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium citrate, sorbitol, purified water.


Questions



888-974-5279


Other



Manufactured by:

Silarx Pharmaceuticals, Inc.
1033 Stoneleigh Ave
Carmel, NY 10512
USA

Relabeled By: Preferred Pharmaceuticals Inc.


* Please review the disclaimer below.