Label: ALKA-SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescent
- NDC Code(s): 70264-016-01
- Packager: R J General Corporation
- This is a repackaged label.
- Source NDC Code(s): 0280-0022
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated October 16, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- 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 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 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
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
- Inactive ingredients
- QUESTIONS
- KEEP OUT OF REACH OF CHILDREN
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PRINCIPAL DISPLAY PANEL - 60 Tablet Carton
Alka-
Seltzer
PLUS ®
Acetaminophen / Pain reliever/fever reducer
Chlorpheniramine maleate / Antihistamine
Dextromethorphan hydrobromide / Cough suppressant
Phenylephrine hydrochloride / Nasal decongestantCOLD
FORMULASPARKLING
ORIGINALNasal Congestion • Runny Nose
Headache & Body Ache
Sore Throat • Sinus Pressure
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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:70264-016(NDC:0280-0022) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 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:70264-016-01 30 in 1 CARTON 03/16/2023 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 Drug M012 03/16/2023 Labeler - R J General Corporation (122542830) Establishment Name Address ID/FEI Business Operations R J General Corporation 122542830 repack(70264-016)