Label: FIRST AID DIRECT COUGH RELIEF DM- guaifenesin dextromethorphan hbr syrup
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Contains inactivated NDC Code(s)
NDC Code(s): 42961-121-01, 42961-121-02 - Packager: Cintas 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 August 10, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- Active ingredients (each 5mL/1 teaspoon)
- Purposes
- Uses
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Warnings
Do not use
this product for persistent or chronic cough such as occurs with smoking, asthma, emphysema or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor. 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 are uncertain whether your prescription drug contains an MAOI, consult a health professional before taking this product.
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
do not take more than 6 doses in 24 hours, or as directed by a doctor.
- adults and children 12 years and over, take one premeasured single dose dispenser (2 teaspoons) every 4 hours
- children 6-11 years, measure out and take only 1 teaspoon every 4 hours
- children 2 to 5 years, measure out and take only 1/2 teaspoon every 4 hours
- children under 2 years, consult your doctor
- Other information
- Inactive ingredients
- Questions?
- Package Label Principal Display Panel Single Dose Pack
- Package Label Principal Display Panel Box
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INGREDIENTS AND APPEARANCE
FIRST AID DIRECT COUGH RELIEF DM
guaifenesin dextromethorphan hbr syrupProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-121 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 DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SODIUM CITRATE (UNII: 1Q73Q2JULR) SUCRALOSE (UNII: 96K6UQ3ZD4) PROPYLPARABEN (UNII: Z8IX2SC1OH) METHYLPARABEN (UNII: A2I8C7HI9T) WATER (UNII: 059QF0KO0R) Product Characteristics Color Score Shape Size Flavor CHERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-121-02 6 in 1 BOX 05/13/2022 1 NDC:42961-121-01 10 mL in 1 DOSE 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 05/13/2022 Labeler - Cintas Corporation (056481716) Establishment Name Address ID/FEI Business Operations ULTRAtab Laboratories, Inc. 151051757 manufacture(42961-121)