Label: ALKA-SELTZER PLUS MAXIMUM STRENGTH SINUS CONGESTION AND PAIN POWERFAST FIZZ- chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride tablet, effervescent
- NDC Code(s): 0280-0055-01, 0280-0055-02
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated December 6, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
-
WARNINGS
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
· more than 4,000 mg of acetaminophen in 24 hours
· with other drugs containing acetaminophen
· 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 to sedate children.
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 12 years of age
Ask a doctor or pharmacist before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
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 children
Stop use and ask a doctor if
- pain, cough, or nasal congestion gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- cough comes back or occurs with rash or headache that lasts. These
- could be signs of a serious condition.
- nervousness, dizziness, or sleeplessness occurs
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
-
PRINCIPAL DISPLAY PANEL
Alka-Seltzer Plus®
MAXIMUM STRENGTH
Sinus
Congestion
& Pain
PowerFast Fizz™
Berry
New!
Actaminophen/Pain Reliever-Fever Reducer
Chlorpheniramine Maleate/Antihistamine
Dextromethorphan HBr/Cough Supressant
Phenylephrine Hydrochloride/Nasal Decongestant
- Sinus Congestion & Pressure
- Nasal Congestion
- Headache, Body Ache, Sore Throat
- Runny Nose, Sneezing
- Cough
24 EFFERVESCENT TABLETS
-
INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS MAXIMUM STRENGTH SINUS CONGESTION AND PAIN POWERFAST FIZZ
chlorpheniramine maleate, dextromethorphan hydrobromide, acetaminophen, phenylephrine hydrochloride tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0055 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength CALCIUM SILICATE (UNII: S4255P4G5M) MANNITOL (UNII: 3OWL53L36A) MAGNESIUM STEARATE (UNII: 70097M6I30) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) SODIUM BICARBONATE (UNII: 8MDF5V39QO) SUCRALOSE (UNII: 96K6UQ3ZD4) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) MALTODEXTRIN (UNII: 7CVR7L4A2D) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DIMETHICONE (UNII: 92RU3N3Y1O) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor BERRY (Raspberry and Mixed Berry) Imprint Code SINUS Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0055-01 10 in 1 CARTON 06/15/2021 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0280-0055-02 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 06/15/2021 Labeler - Bayer HealthCare LLC. (112117283)