Label: ONLY FOR COUGH- guaifenesin, dextromethorphan hbr tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 73006-101-41 - Packager: O4 Global Trading Usa, Llc
- 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 28, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- DRUG FACTS
- Active ingredient (in each tablet)
- 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 if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
• if you have a chronic pulmonary disease or shortness of breath unless directed by a doctor.
Stop use and consult a doctor
• if cough lasts more than 7 days, recurs or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Ask a doctor before use if you have
• persistent cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
• cough accompanied by too much phlegm (mucus)
When using this product
• do not exceed recommended dosage.
• do not use for more than 7 days
May cause or aggravate constipation.
If pregnant or breast-feeding,
ask a healthcare professional before use.
- Directions:
- Other Information:
- Inactive Ingredients:
- Questions Or Comments ?
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SPL UNCLASSIFIED SECTION
NDC: 73006-101-41
Distributed By: O4 GLOBAL TRADING USA LLC., 2241 S Watson RD, Suite 121 Arlington, TX 76010.
www.onlyfor.com
Packaged By: Strive Pharmaceuticals Inc., East Brunswick, NJ 08816.
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF A BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING.
Tear along perforation push product through foil
- Packaging
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INGREDIENTS AND APPEARANCE
ONLY FOR COUGH
guaifenesin, dextromethorphan hbr tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:73006-101 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) MAGNESIUM PALMITOSTEARATE (UNII: R4OXA9G5BV) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE 101 (UNII: 7T9FYH5QMK) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) TALC (UNII: 7SEV7J4R1U) Product Characteristics Color white Score no score Shape OVAL (Oblong) Size 17mm Flavor Imprint Code S55 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:73006-101-41 1 in 1 CARTON 03/29/2019 1 4 in 1 BLISTER PACK; 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 03/29/2019 Labeler - O4 Global Trading Usa, Llc (081226861)
