Label: ALKA SELTZER PLUS MAXIMUM STRENGTH COUGH CHEST CONGESTION POWERFAST FIZZ- dextromethorphan hydrobromide, guaifenesin tablet, effervescent
- NDC Code(s): 0280-0089-01
- Packager: Bayer Healthcare 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.
Updated April 5, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Questions or comments
- Carton 20 count
INGREDIENTS AND APPEARANCE
ALKA SELTZER PLUS MAXIMUM STRENGTH COUGH CHEST CONGESTION POWERFAST FIZZ
dextromethorphan hydrobromide, guaifenesin tablet, effervescent
Product 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/05/2022 Labeler - Bayer Healthcare LLC. (112117283)