Label: ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescent
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NDC Code(s):
0280-0022-01,
0280-0022-02,
0280-0022-03,
0280-0022-04, view more0280-0022-05
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated August 15, 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
- INDICATIONS & USAGE
-
WARNINGS
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 before use if you have
● liver disease ● heart disease ● high blood pressure
● thyroid disease ● diabetes ● glaucoma
● cough with excessive phlegm (mucus)
● a breathing problem such as emphysema or chronic bronchitis
● difficulty in urination due to enlargement of the prostate gland
● persistent or chronic cough such as occurs with smoking, asthma,
or emphysema
● a sodium restricted diet
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 childre
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
- Directions
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- Questions or comments
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0022 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 CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) DIMETHICONE (UNII: 92RU3N3Y1O) CALCIUM SILICATE (UNII: S4255P4G5M) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) FD&C RED NO. 40 (UNII: WZB9127XOA) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) SUCRALOSE (UNII: 96K6UQ3ZD4) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color white (Speckled) Score no score Shape ROUND Size 25mm Flavor Imprint Code ASP;FLU Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0022-01 10 in 1 CARTON 04/01/2020 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0280-0022-02 36 in 1 CARTON 09/15/2021 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:0280-0022-03 3200 in 1 BOX 02/01/2022 3 1 in 1 BOX; Type 0: Not a Combination Product 4 NDC:0280-0022-04 24 in 1 CARTON 03/09/2022 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:0280-0022-05 12 in 1 CARTON 03/06/2023 5 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 04/01/2020 Labeler - Bayer HealthCare LLC. (112117283)
