Label: ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ ORANGE ZEST- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
- NDC Code(s): 0280-0020-01, 0280-0020-02
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated January 17, 2025
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- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- Uses
- Directions
-
WARNINGS
Warnings
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include:
● hives ● facial swelling ● asthma (wheezing) ● shock
Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you
● are age 60 or older
● have had stomach ulcers or bleeding problems
● take a blood thinning (anticoagulant) or steroid drug
● take other drugs containing prescription or nonprescription NSAIDs
(aspirin, ibuprofen, naproxen, or others)
● have 3 or more alcoholic drinks every day while using this product
● take more or for a longer time than directed
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
● if you are allergic to aspirin or any other pain reliever/fever reducer
● 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
● stomach bleeding warning applies to you
● you have a history of stomach problems, such as heartburn
● you have high blood pressure, heart disease, liver cirrhosis,
or kidney disease
● you are taking a diuretic
● you have
● asthma ● diabetes
● thyroid disease ● glaucoma
● difficulty in urination due to enlargement of the prostate gland
● a breathing problem such as emphysema or chronic bronchitis
● a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
· taking a prescription drug for
· gout · diabetes · arthritis
· taking sedatives or tranquilizers
When using this product
● do not exceed recommended dosage
● excitability may occur, especially in children
● you may get drowsy
● avoid alcoholic drinks
● alcohol, sedatives, and tranquilizers may increase drowsiness
● be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
● an allergic reaction occurs. Seek medical help right away.
● you experience any of the following signs of stomach bleeding
● feel faint ● vomit blood ● have bloody or black stools
● have stomach pain that does not get better
● pain 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
● ringing in the ears or a loss of hearing occurs
● nervousness, dizziness, or sleeplessness occur
- Other information
- Inactive ingredients
- Questions or Comments
-
Carton 24 count
Alka-Seltzer PLUS® Severe Cold Orange Zest
PowerFast Fizz™
NEW Improved Flavor
ASPIRIN (NSAID) / Pain Reliever-Fever Reducer
Chlorheniramine Maleate / Antihistamine
Phenylephrine Bitartrate / Nasal Decongestant
- Nasal Congestion
- Runny Nose
- Sore Throat
- Headache + Body Ache
- Sinus Pressure
24 EFFERVESCENT TABLETS
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INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ ORANGE ZEST
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0020 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg Inactive Ingredients Ingredient Name Strength FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SUCRALOSE (UNII: 96K6UQ3ZD4) MANNITOL (UNII: 3OWL53L36A) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) SODIUM BICARBONATE (UNII: 8MDF5V39QO) POVIDONE (UNII: FZ989GH94E) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C RED NO. 40 (UNII: WZB9127XOA) CALCIUM SILICATE (UNII: S4255P4G5M) DIMETHICONE (UNII: 92RU3N3Y1O) Product Characteristics Color white (SPOTTED) Score no score Shape ROUND Size 25mm Flavor ORANGE Imprint Code ASP;ORANGE Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0020-01 10 in 1 CARTON 07/01/2020 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0280-0020-02 12 in 1 CARTON 03/30/2023 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 07/01/2020 Labeler - Bayer HealthCare LLC. (112117283)