Label: CHEST CONGESTION RELIEF- guaifenesin and dextromethorphan hbr tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 70677-0012-1 - Packager: Mckesson
- 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 18, 2016
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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 your prescription drug contains an MAOI ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- cough accompanied by too much of phelgm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- when using this product do not use more than directed
Stop use and ask doctor if
Cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache, these could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
- Keep out of reach of children.
- Directions
- Other Information
- Inactive Ingredients
- Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CHEST CONGESTION RELIEF
guaifenesin and dextromethorphan hbr tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70677-0012 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 16mm Flavor Imprint Code TCL;280 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70677-0012-1 50 in 1 BOTTLE 11/25/2016 1 1 in 1 CARTON; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 11/25/2016 Labeler - Mckesson (177667227)