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
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated May 16, 2023
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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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 07/01/1997 Labeler - Efficient Laboratories Inc. (969044932) Registrant - Efficient Laboratories Inc. (969044932) Establishment Name Address ID/FEI Business Operations Dextrum Laboratories Inc. 007392322 manufacture(58593-255)
