Label: MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM- maximum strength-cough and chest congestion dm capsule, liquid filled
- NDC Code(s): 53345-034-01
- Packager: Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
- 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.
Updated June 24, 2015
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each softgel)
Dextromethorphan HBr, USP 10 mg
Guaifenesin, USP 200 mgClose
- temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
- helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
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.
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
Stop use and ask a doctor if
cough lasts for more than 7 days, comes back, or is accompanied by fever, rash, or persistent headache. These could be signs of a serious condition.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
• do not take more than 12 softgels in any 24-hour period
• this adult product is not intended for use in children under 12 years of age
adults and children 12 years and over
2 softgels every 4 hours
children under 12 years
do not use
- Other information
• store at room temperature 15-30°C (59-86°F)Close
• avoid excessive heat above 40°C (104°F)
- Inactive ingredients
FD&C Red #40, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special and white edible ink
Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.
- PRINCIPAL DISPLAY PANEL - Shipping Label
Maximum Strength-Cough and Chest Congestion DM Liquid Filled Capsules
Quantity : 4000 Capsules
NDC. No : 53345-034-01
- Inspect immediately upon receipt.
- This is a bulk shipment, intended for further processing only.
- Protect from heat, humidity, and light. Do not refrigerate.
- Store at 15-30°C (59-86°F)
CAUTION : FOR FURTHER MANUFACTURING, PROCESSING OR REPACKAGING
- INGREDIENTS AND APPEARANCE
MAXIMUM STRENGTH-COUGH AND CHEST CONGESTION DM
maximum strength-cough and chest congestion dm capsule, liquid filled
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53345-034 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg Inactive Ingredients Ingredient Name Strength FD&C RED NO. 40 (UNII: WZB9127XOA) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) WATER (UNII: 059QF0KO0R) Product Characteristics Color red Score no score Shape CAPSULE (OBLONG) Size 18mm Flavor Imprint Code PC37 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53345-034-01 1 in 1 BOX 1 4000 in 1 BAG; 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 06/30/2015 Labeler - Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. (421293287) Establishment Name Address ID/FEI Business Operations Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd. 421293287 MANUFACTURE(53345-034) , ANALYSIS(53345-034)