Label: ALKA SELTZER COLD COLD CONGESTION SEVERE DAY NIGHT FAST DISSOLVE- aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate kit
- NDC Code(s): 0280-8285-24, 0280-8285-48
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 27, 2026
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
-
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
● 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 •thyroid disease • diabetes
- cough that is accompanied by excessive phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- difficulty in urination due to enlargement of the prostate gland
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are taking a prescription drug for diabetes, gout, or arthritis
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, 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.
- ringing in the ears or loss of hearing occurs
- nervousness, dizziness, or sleeplessness occurs
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- SPL UNCLASSIFIED SECTION
-
ACTIVE INGREDIENT
Active ingredients (in each tablet) Purposes
Aspirin 325 mg (NSAID)*…….…………………..Pain reliever/fever reducer
Chlorpheniramine maleate 2mg ……….……..…..………...…Antihistamine
Dextromethorphan hydrobromide 10 mg……..…..……Cough suppressant
Phenylephrine bitartrate 7.8 mg.......…………..…...….Nasal decongestant
*nonsteroidal anti-inflammatory drug
- PURPOSE
- INDICATIONS & USAGE
-
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
- cough that is accompanied by excessive phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma,or emphysema
- a breathing problem such as emphysema or chronic bronchitis
- difficulty in urination due to enlargement of the prostate gland
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- taking a prescription drug for diabetes, gout, or arthritis
- taking sedatives or tranquilizers
When using this product
- do not exceed recommended dosage
- may cause marked drowsiness
- alcohol, sedatives, and tranquilizers may increase the drowsiness effect
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
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, 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.
- ringing in the ears or loss of hearing occurs
- nervousness, dizziness, or sleeplessness occurs
- DOSAGE & ADMINISTRATION
- OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
ALKA SELTZER COLD COLD CONGESTION SEVERE DAY NIGHT FAST DISSOLVE
aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-8285 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-8285-24 1 in 1 CARTON; Type 0: Not a Combination Product 06/01/2026 2 NDC:0280-8285-48 1 in 1 CARTON; Type 0: Not a Combination Product 06/01/2026 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 16 POUCH 32 Part 2 8 POUCH 16 Part 3 4 POUCH 8 Part 4 8 POUCH 16 Part 1 of 4 ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ NON DROWSY
asprin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescentProduct Information Item Code (Source) NDC:0280-0024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength CALCIUM SILICATE (UNII: S4255P4G5M) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SUCRALOSE (UNII: 96K6UQ3ZD4) DIMETHICONE (UNII: 92RU3N3Y1O) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MANNITOL (UNII: 3OWL53L36A) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) POVIDONE (UNII: FZ989GH94E) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color white (SPECKLED) Score no score Shape ROUND Size 25mm Flavor CITRUS Imprint Code ASP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 06/01/2026 Part 2 of 4 ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ NON DROWSY
asprin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescentProduct Information Item Code (Source) NDC:0280-0024 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength CALCIUM SILICATE (UNII: S4255P4G5M) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) SUCRALOSE (UNII: 96K6UQ3ZD4) DIMETHICONE (UNII: 92RU3N3Y1O) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MANNITOL (UNII: 3OWL53L36A) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) POVIDONE (UNII: FZ989GH94E) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color white (SPECKLED) Score no score Shape ROUND Size 25mm Flavor CITRUS Imprint Code ASP Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 06/01/2026 Part 3 of 4 ALKA-SELTZER PLUS SEVERE COLD NIGHT POWERFAST FIZZ
aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescentProduct Information Item Code (Source) NDC:0280-0121 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) DIMETHICONE (UNII: 92RU3N3Y1O) CALCIUM SILICATE (UNII: S4255P4G5M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor LEMON, LEMON Imprint Code ASP;NT Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 06/01/2026 Part 4 of 4 ALKA-SELTZER PLUS SEVERE COLD NIGHT POWERFAST FIZZ
aspirin, chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescentProduct Information Item Code (Source) NDC:0280-0121 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength SUCRALOSE (UNII: 96K6UQ3ZD4) SODIUM BICARBONATE (UNII: 8MDF5V39QO) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) MANNITOL (UNII: 3OWL53L36A) POVIDONE (UNII: FZ989GH94E) DIMETHICONE (UNII: 92RU3N3Y1O) CALCIUM SILICATE (UNII: S4255P4G5M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor LEMON, LEMON Imprint Code ASP;NT Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 06/01/2026 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 06/01/2026 Labeler - Bayer HealthCare LLC. (112117283)
