Label: ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ- aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate kit
- NDC Code(s): 0280-0025-01
- Packager: Bayer HealthCare LLC.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 4, 2023
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Product
- Drug Facts
- Active ingredients
- Purpose
- Uses
-
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
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
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 with excessive phlegm (mucus)
● 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
Ask a doctor or pharmacist before use if you are
· taking a prescription drug for
· gout · diabetes · arthritis
Stop use
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
· ringing in the ears or a loss of hearing occurs
· cough comes back or occurs with rash or headache that lasts. These
could be signs of a serious condition.
· nervousness, dizziness, or sleeplessness occurs
Pregnant or breastfeeding
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Directions
- Other information
- Inactive ingredients
- Questions or comments
- Drug Facts
-
Active ingredients
Active ingredients (in each tablet) Purposes
Aspirin 500 mg (NSAID)*….………………….Pain reliever/fever reducer
Dextromethorphan hydrobromide 10 mg……………Cough suppressant
Doxylamine succinate 6.25 mg…………………………...…Antihistamine
Phenylephrine bitartrate 7.8 mg.......…………….….Nasal decongestant
*nonsteroidal anti-inflammatory drug
- Purpose
- Uses
-
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
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 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
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 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
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
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
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
● ringing in the ears or a loss of hearing occurs
● cough comes back or occurs with rash or headache that lasts. These
could be signs of a serious condition.
● nervousness, dizziness, or sleeplessness occurs
If pregnant or breast-feeding
If pregnant or breast-feeding, ask a health professional before use.
It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
- Directions
- Other information
- Inactive ingredients
- Questions or comments
-
Package display
Alka-Seltzer
Plus®
SEVERE
Cold
POWERFAST FIZZ™
DAY/CITRUS
NIGHT/LEMON
NEW IMPROVED FLAVOR
DAY NON-DROWSY
ASPIRIN (NSAID) / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Phenylephrine Bitartrate / Nasal Decongestant
- Nasal Congestion
- Headache + Body Ache
- Cough
- Sore Throat
- Sinus Pressure
12 EFFERVESCENT TABLETS
NIGHT
ASPIRIN (NSAID) / Pain Reliever-Fever Reducer
Dextromethorphan HBr / Cough Suppressant
Doxylamine Succinate / Antihistamine
Phenylephrine Bitartrate / Nasal Decongestant
- Nasal Congestion
- Headache + Body Ache
- Cough
- Runny Nose
- Sore Throat
8 EFFERVESCENT TABLETS
-
INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate, doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0280-0025 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0280-0025-01 1 in 1 CARTON; Type 0: Not a Combination Product 04/01/2020 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 CARTON 12 Part 2 1 CARTON 8 Part 1 of 2 ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ DAY NON DROWSY
aspirin, dextromethorphan hydrobromide, phenylephrine bitartrate tablet, effervescentProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg Inactive Ingredients Ingredient Name Strength MANNITOL (UNII: 3OWL53L36A) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DIMETHICONE (UNII: 92RU3N3Y1O) FD&C RED NO. 40 (UNII: WZB9127XOA) SUCRALOSE (UNII: 96K6UQ3ZD4) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) POVIDONE (UNII: FZ989GH94E) SODIUM BICARBONATE (UNII: 8MDF5V39QO) CALCIUM SILICATE (UNII: S4255P4G5M) 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 12 in 1 CARTON; 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 04/20/2020 Part 2 of 2 ALKA-SELTZER PLUS SEVERE COLD POWERFAST FIZZ NIGHT
aspirin, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine bitartrate tablet, effervescentProduct Information Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 500 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg Inactive Ingredients Ingredient Name Strength CALCIUM SILICATE (UNII: S4255P4G5M) POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) POVIDONE (UNII: FZ989GH94E) SODIUM BICARBONATE (UNII: 8MDF5V39QO) DIMETHICONE (UNII: 92RU3N3Y1O) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) MANNITOL (UNII: 3OWL53L36A) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor LEMON Imprint Code ASP;NT Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 8 in 1 CARTON; 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 04/20/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 04/01/2020 Labeler - Bayer HealthCare LLC. (112117283)