Label: COUGH OUT- guaifenesin liquid
- NDC Code(s): 58593-255-04, 58593-255-06
- Packager: Efficient Laboratories Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 18, 2025
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
WARNINGS
Warnings
Do not exceed recommended dosage
Ask a doctor before use if you have
- a cough that is accompanied by excessive phlegm (mucus)
- a persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema.
Stop use and ask a doctor if
- cough persists for more than 1 week, tends to recur, or is accompanied by a fever, rash, or persstent headached. A persistent cough may be a sign of a serious condition.
- KEEP OUT OF REACH OF CHILDREN
- PREGNANCY OR BREAST FEEDING
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- OTHER SAFETY INFORMATION
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
COUGH OUT
guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58593-255 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 100 mg in 5 mL Inactive Ingredients Ingredient Name Strength ALOE VERA LEAF (UNII: ZY81Z83H0X) HONEY (UNII: Y9H1V576FH) MENTHOL (UNII: L7T10EIP3A) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) ASPARTAME (UNII: Z0H242BBR1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58593-255-04 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/1997 05/16/2023 2 NDC:58593-255-06 178 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/01/1997 10/31/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 07/01/1997 10/31/2026 Labeler - Efficient Laboratories Inc. (969044932) Registrant - Efficient Laboratories Inc. (969044932)

