Label: ALTITUSS- dextromethorphan hbr, guaifenesin liquid
- NDC Code(s): 53163-113-16
- Packager: Alternative Pharmacal Corporation
- 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 December 23, 2020
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- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
DO NOT USE
If you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric or emotional conditions or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if you are taking a prescription drug that contains MAOI; ask your doctor or pharmacist before taking this product.
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
When using this product do not use more than directed.
Stop use and ask a doctor before use 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.
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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DOSAGE & ADMINISTRATION
Directions Do not take more than 6 doses in any 24-hour period.
Adults and children 12 years of age and over 10 ml (2tsp) every 4 hours Children 6 years to under 12 years of age 5 ml (1tsp) every 4 hours Children 2 years to under 6 years of age 2.5 ml (1/2 tsp) every 4 hours Children under 2 years Consult a doctor - INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
ALTITUSS
dextromethorphan hbr, guaifenesin liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53163-113 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 mg in 7.5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 150 mg in 7.5 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53163-113-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/01/2015 Labeler - Alternative Pharmacal Corporation (078528214)
