Label: ALKA SELTZER PLUS MAXIMUM STRENGTH COUGH CHEST CONGESTION POWERFAST FIZZ- dextromethorphan hydrobromide, guaifenesin tablet, effervescent
- NDC Code(s): 0280-0089-01, 0280-0089-02
- Packager: Bayer Healthcare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2024
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
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WARNINGS
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 ever had an allergic reaction to this product or any of its Ingredients
● in children under 12 years of age
Ask a doctor before use if you have
● cough that occurs with excessive phlegm (mucus) ● persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema ● a sodium-restricted diet
Stop use and ask a doctor if cough lasts more than 7 days, comes back, or is accompanied by a 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 SAFETY INFORMATION
- INACTIVE INGREDIENT
- Questions or comments
- Carton 24 count
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INGREDIENTS AND APPEARANCE
ALKA SELTZER PLUS MAXIMUM STRENGTH COUGH CHEST CONGESTION POWERFAST FIZZ
dextromethorphan hydrobromide, guaifenesin tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0089 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 CALCIUM SILICATE (UNII: S4255P4G5M) DIMETHICONE (UNII: 92RU3N3Y1O) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) POVIDONE (UNII: FZ989GH94E) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor CITRUS Imprint Code ASP;CandC Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0089-01 20 in 1 CARTON 04/05/2022 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0280-0089-02 12 in 1 CARTON 03/08/2023 2 2 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/05/2022 Labeler - Bayer Healthcare LLC. (112117283)