Label: ALKA-SELTZER PLUS COLD AND FLU, CVP- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent
ALKA-SELTZER PLUS COLD AND FLU, BASIX- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent
ALKA-SELTZER PLUS COLD AND FLU- chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescent
-
NDC Code(s):
66715-6531-2,
66715-7831-2,
66715-9831-2,
66715-9831-8, view more66715-9831-9
- Packager: Lil' Drug Store Products, Inc.
- Category: HUMAN OTC DRUG LABEL
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 April 12, 2023
If you are a healthcare professional or from the pharmaceutical industry please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active ingredients
- Purposes
- Uses
-
Warnings
Liver warning
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert
Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:
- skin reddening
- blisters
- rash
- hives
- facial swelling
- asthma (wheezing)
- shock
If a skin or general allergic reaction occurs, stop use and seek medical help right away.
Sore throat warning
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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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 you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- 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 before use if you are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
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
- 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.
- nervousness, dizziness, or sleeplessness occurs
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
-
PDP/Package - Lil Drug Store
Alka-
Seltzer
Plus ®
CITRUS
FLAVOR
SEVERE Cold & Flu
POWERFAST FIZZ™
ACETAMINOPHEN/Pain Reliever-Fever Reducer
Chlorpheniramine Maleate/Antihistamine
Dextromethorphan HBr/Cough Suppressant
Phenylephrine Hydrochloride/Nasal Decongestant
- Fever & Body Ache
- Cough
- Nasal Congestion
- Runny Nose
- Sore Throat
4
Effervescent Tablets
[Lil' Drug Store logo]
-
PDP/Package - BASIX
Alka-
Seltzer
Plus ®
CITRUS
FLAVOR
SEVERE Cold & Flu
POWERFAST FIZZ™
ACETAMINOPHEN/Pain Reliever-Fever Reducer
Chlorpheniramine Maleate/Antihistamine
Dextromethorphan HBr/Cough Suppressant
Phenylephrine Hydrochloride/Nasal Decongestant
- Fever & Body Ache
- Cough
- Nasal Congestion
- Runny Nose
- Sore Throat
4
Effervescent Tablets
[TRAVEL
BASIX logo]
-
PDP/Package - Alka-Selter Plus Cold & Flu, CVP
Alka-
Seltzer
Plus ®
CITRUS
FLAVOR
SEVERE Cold & Flu
POWERFAST FIZZ™
ACETAMINOPHEN/Pain Reliever-Fever Reducer
Chlorpheniramine Maleate/Antihistamine
Dextromethorphan HBr/Cough Suppressant
Phenylephrine Hydrochloride/Nasal Decongestant
- Fever & Body Ache
- Cough
- Nasal Congestion
- Runny Nose
- Sore Throat
4
Effervescent Tablets
[CVP HEALTH logo]
-
Alka-Seltzer Plus Cold & Flu, 25ct Unit Dose Box
Alka-
Seltzer
PLUS ®
CITRUS
FLAVOR
SEVERE COLD & FLU
POWERFAST FIZZ™
ACETAMINOPHEN/Pain Reliever-Fever Reducer
Chlorpheniramine Maleate/Antihistamine
Dextromethorphan HBr/Cough Suppressant
Phenylephrine Hydrochloride/Nasal Decongestant
- Fever & Body Ache
- Cough
- Nasal Congestion
- Runny Nose
- Sore Throat
2 EFFERVESCENT TABLETS PER POUCH
-
Alka-Seltzer Plus Cold & Flu, 30ct Unit Dose Box
Alka-
Seltzer
PLUS ®
CITRUS
FLAVOR
SEVERE COLD & FLU
POWERFAST FIZZ™
ACETAMINOPHEN/Pain Reliever-Fever Reducer
Chlorpheniramine Maleate/Antihistamine
Dextromethorphan HBr/Cough Suppressant
Phenylephrine Hydrochloride/Nasal Decongestant
- Fever & Body Ache
- Cough
- Nasal Congestion
- Runny Nose
- Sore Throat
2 EFFERVESCENT TABLETS PER POUCH
-
INGREDIENTS AND APPEARANCE
ALKA-SELTZER PLUS COLD AND FLU, CVP
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-6531 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg Inactive Ingredients Ingredient Name Strength POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM BICARBONATE (UNII: 8MDF5V39QO) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCRALOSE (UNII: 96K6UQ3ZD4) CALCIUM SILICATE (UNII: S4255P4G5M) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color white (speckled) Score no score Shape ROUND Size 25mm Flavor CITRUS Imprint Code ASP;FLU Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-6531-2 2 in 1 CARTON 08/01/2022 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 final part341 04/25/2022 ALKA-SELTZER PLUS COLD AND FLU, BASIX
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-7831 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg Inactive Ingredients Ingredient Name Strength POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM BICARBONATE (UNII: 8MDF5V39QO) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCRALOSE (UNII: 96K6UQ3ZD4) CALCIUM SILICATE (UNII: S4255P4G5M) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color white (speckled) Score no score Shape ROUND Size 25mm Flavor CITRUS Imprint Code ASP;FLU Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-7831-2 2 in 1 CARTON 11/30/2022 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 final part341 11/30/2022 ALKA-SELTZER PLUS COLD AND FLU
chlorpheniramine maleate, acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide tablet tablet, effervescentProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66715-9831 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg Inactive Ingredients Ingredient Name Strength POTASSIUM BICARBONATE (UNII: HM5Z15LEBN) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) SODIUM BICARBONATE (UNII: 8MDF5V39QO) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) DIMETHICONE (UNII: 92RU3N3Y1O) MAGNESIUM STEARATE (UNII: 70097M6I30) MALTODEXTRIN (UNII: 7CVR7L4A2D) SUCRALOSE (UNII: 96K6UQ3ZD4) CALCIUM SILICATE (UNII: S4255P4G5M) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MANNITOL (UNII: 3OWL53L36A) Product Characteristics Color white (speckled) Score no score Shape ROUND Size 25mm Flavor CITRUS Imprint Code ASP;FLU Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66715-9831-2 2 in 1 CARTON 04/25/2022 1 2 in 1 POUCH; Type 0: Not a Combination Product 2 NDC:66715-9831-8 25 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 04/27/2022 3 NDC:66715-9831-9 30 in 1 BOX, UNIT-DOSE; Type 0: Not a Combination Product 05/17/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/25/2022 Labeler - Lil' Drug Store Products, Inc. (093103646)