Label: ALKA SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescent tablet, effervescent
52904-830-25, view more52904-830-30
- Packager: Select Corporation
- This is a repackaged label.
- Source NDC Code(s): 0280-0022
- 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 May 12, 2022
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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
Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
- skin reddening
- facial swelling
- asthma (wheezing)
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
- 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 a rash or headache that lasts. These could be signs of a serious condition.
- nervousness, dizziness, or sleeplessness occurs
- Other information
- Inactive ingredients
- Questions or comments?
PRINCIPAL DISPLAY PANEL - 2 Tablet Pouch Blister Pack
ACETAMINOPHEN / Pain Reliever-Fever Reducer
Chlorpheniramine Maleate / Antihistamine
Dextromethorphan HBr / Cough Suppressant
Phenylephrine Hydrochloride / Nasal Decongestant
• Fever & Body Ache • Cough • Nasal Congestion
• Runny Nose • Sore Throat
POWER FAST FiZZ™
INGREDIENTS AND APPEARANCE
ALKA SELTZER PLUS SEVERE COLD AND FLU POWERFAST FIZZ
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet, effervescent tablet, effervescent
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52904-830(NDC:0280-0022) Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D) Acetaminophen 250 mg Dextromethorphan hydrobromide (UNII: 9D2RTI9KYH) (Dextromethorphan - UNII:7355X3ROTS) Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride (UNII: 04JA59TNSJ) (Phenylephrine - UNII:1WS297W6MV) Phenylephrine hydrochloride 5 mg Chlorpheniramine maleate (UNII: V1Q0O9OJ9Z) (Chlorpheniramine - UNII:3U6IO1965U) Chlorpheniramine maleate 2 mg Inactive Ingredients Ingredient Name Strength acesulfame potassium (UNII: 23OV73Q5G9) anhydrous citric acid (UNII: XF417D3PSL) FD&C red no. 40 (UNII: WZB9127XOA) magnesium stearate (UNII: 70097M6I30) maltodextrin (UNII: 7CVR7L4A2D) mannitol (UNII: 3OWL53L36A) saccharin sodium (UNII: SB8ZUX40TY) sodium bicarbonate (UNII: 8MDF5V39QO) Product Characteristics Color WHITE (Speckled) Score no score Shape ROUND Size 25mm Flavor CITRUS Imprint Code ASP;FLU Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52904-830-04 1 in 1 BLISTER PACK 07/03/2017 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:52904-830-05 2 in 1 BLISTER PACK 07/03/2017 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:52904-830-20 20 in 1 CARTON 07/03/2017 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:52904-830-25 25 in 1 CARTON 07/03/2017 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:52904-830-30 30 in 1 CARTON 07/03/2017 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 FINAL part341 07/03/2017 Labeler - Select Corporation (053805599)