Label: ALKA-SELTZER PLUS COLD SPARKLING ORIGINAL POWERFAST FIZZ- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
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NDC Code(s):
0280-0060-01,
0280-0060-02,
0280-0060-03,
0280-0060-04, view more0280-0060-05, 0280-0060-06
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated May 21, 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
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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
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
● 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
Ask a doctor or pharmacist before use if you are
taking a prescription drug for
- gout
- diabetes
- arthritis
taking sedatives or tranquilizers
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
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PRINCIPAL DISPLAY PANEL
Alka-Seltzer Plus®
Severe Cold
Sparkling Original
POWERFAST FIZZ™
NEW LESS RESIDUE
ASPIRIN (NSAID)/Pain Reliever-Fever Reducer
Chlorpheniramine 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 COLD SPARKLING ORIGINAL POWERFAST FIZZ
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0060 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength DIMETHICONE (UNII: 92RU3N3Y1O) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) SUCRALOSE (UNII: 96K6UQ3ZD4) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) CALCIUM SILICATE (UNII: S4255P4G5M) MANNITOL (UNII: 3OWL53L36A) SODIUM BICARBONATE (UNII: 8MDF5V39QO) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor LEMON Imprint Code ALKA;SELTZERplus Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0060-01 10 in 1 CARTON 06/15/2021 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:0280-0060-02 18 in 1 CARTON 06/15/2021 2 2 in 1 POUCH; Type 0: Not a Combination Product 3 NDC:0280-0060-03 2 in 1 CARTON 04/01/2022 3 2 in 1 POUCH; Type 0: Not a Combination Product 4 NDC:0280-0060-04 12 in 1 CARTON 03/30/2023 4 2 in 1 POUCH; Type 0: Not a Combination Product 5 NDC:0280-0060-05 2 in 1 POUCH; Type 0: Not a Combination Product 06/15/2021 6 NDC:0280-0060-06 24 in 1 CARTON 03/30/2023 6 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)