Label: ALKA-SELTZER PLUS COUGH AND SORE THROAT FIZZYCHEWS- acetaminophen, dextromethorphan hydrobromide tablet, chewable
- NDC Code(s): 0280-0152-01, 0280-0152-02
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated March 26, 2024
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
· adult takes more than 4,000 mg of acetaminophen in 24 hours
· child takes more than 5 doses in 24hours
· taken with other drugs containing acetaminophen
· adult has 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin or severe
allergic reactions. Symptoms may include:
· skin reddening · blisters · rash · hives
· facial swelling · asthma (wheezing) · shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
Sore throat warning: If sore throat is severe, persists for more than
2 days, is accompanied or followed by fever, headache, rash, nausea,
or vomiting, consult a doctor promptly.
Do not use
● with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
● 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 6 years of age
Ask a doctor before use if you have
● liver disease
● cough with excessive phlegm (mucus)
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● a sodium restricted diet
When using this product
● do not exceed recommended dosage
● may cause marked drowsiness
● avoid alcoholic drinks
● alcohol, sedatives, and tranquilizers may increase drowsiness
● be careful when driving a motor vehicle or operating machinery
● excitability may occur, especially in childre
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Directions
Directions
· do not take more than the recommended dose
· adults and children 12 years and over: take 2 tablets every 4 hours.
Do not exceed 6 doses (12 tablets) tablets in 24 hours or as directed by a
doctor.
· children 6 to under 12 years: take 2 tablets every 4 hours. Do not
exceed 5 doses (10 tablets) in 24 hours or as directed by a doctor.
· do not swallow tablets whole. Chew or crush tablets completely
before swallowing.
· children under 12 years: do not use
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Questions or comments
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS COUGH AND SORE THROAT FIZZYCHEWS
acetaminophen, dextromethorphan hydrobromide tablet, chewableProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0152 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 162.5 mg Inactive Ingredients Ingredient Name Strength STEARIC ACID (UNII: 4ELV7Z65AP) MAGNESIUM STEARATE (UNII: 70097M6I30) MANNITOL (UNII: 3OWL53L36A) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) XYLITOL (UNII: VCQ006KQ1E) BETADEX (UNII: JV039JZZ3A) SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) Product Characteristics Color white Score no score Shape ROUND Size 17mm Flavor Imprint Code ASP;13 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0152-01 2 in 1 CARTON 04/01/2024 1 8 in 1 BLISTER PACK; Type 0: Not a Combination Product 2 NDC:0280-0152-02 3 in 1 CARTON 04/01/2024 2 8 in 1 BLISTER PACK; 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 04/01/2024 Labeler - Bayer HealthCare LLC. (112117283)
