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
- Packager: Bayer HealthCare LLC.
- 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.
Drug Label Information
Updated August 16, 2023
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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 06/15/2021 Labeler - Bayer HealthCare LLC. (112117283)