Label: CVS MAXIMUM STRENGTH- dextromethorphan hbr, guaifenesin solution
- NDC Code(s): 51316-740-04, 51316-740-08
- Packager: CVS PHARMACY
- 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 March 3, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each 20 mL)
- Purposes
- Uses
- Warnings
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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
- Stop use and ask a doctor if
- If pregnant or breast-feeding,
- Keep out of reach of children.
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Directions
- ▪
- do not take more than 6 doses in any 24-hour period
- ▪
- measure only with dosing cup provided
- ▪
- keep dosing cup with product
- ▪
- ml = milliliter
- ▪
- this adult product is not intended for use in children under 12 years of age
age
dose
adults and children 12 years and over
20 mL every 4 hours
children under 12 years
do not use
- Other information
- Inactive ingredients
- Questions or comments?
-
Package/Label Principal Display Panel
*Compare to the active ingredients of Robitussin® Cough + Chest Congestion DM*
NDC# 51316-740-04
MAXIMUM STRENGTH
Adult
Cough+Chest
Congestion DM
Dextromethorphan HBr (Cough Suppressant)
Guaifenesin (Expectorant)
- •
- Relieves Chest Congestion
- •
- Controls cough
- •
- Thins & Loosens Mucus
Natural Raspberry Flavor
For Ages 12 & Over
4 FL OZ (118 mL)
Distributed By:
*This product is not manufactured or distributed by Pfizer, owner of the registered trademark Robitussin® Cough + Congestion DM.
Package Label For 4 FL OZ (118 mL)
Package Label For 8 FL OZ (237 mL)
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INGREDIENTS AND APPEARANCE
CVS MAXIMUM STRENGTH
dextromethorphan hbr, guaifenesin solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-740 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 20 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 400 mg in 20 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C RED NO. 40 (UNII: WZB9127XOA) MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) POTASSIUM CITRATE (UNII: EE90ONI6FF) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color RED Score Shape Size Flavor RASPBERRY Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-740-04 1 in 1 CARTON 02/17/2023 1 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:51316-740-08 1 in 1 CARTON 02/17/2023 2 237 mL in 1 BOTTLE; 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 02/17/2023 Labeler - CVS PHARMACY (062312574)