Label: BASIC CARE DAYTIME SEVERE COLD AND FLU NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kit
- NDC Code(s): 72288-357-00, 72288-502-72, 72288-721-00
- Packager: Amazon.com Services LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated November 15, 2024
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients (in each caplet) Daytime
- Purpose
-
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- cough due to minor throat and bronchial irritation
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- minor aches and pains
- •
- headache
- •
- fever
- •
- sore throat
- •
- reduces swelling of nasal passages
- •
- temporarily restores freer breathing through the nose
- •
- promotes nasal and/or sinus drainage
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- helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive
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Warnings
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: Acetaminophen may cause severe skin reactions. Symptoms may include:
- •
- skin reddening
- •
- blisters
- •
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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
- •
- 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
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- trouble urinating due to an enlarged prostate gland
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- cough that occurs with too much phlegm (mucus)
- •
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
Stop use and ask a doctor if
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion, or cough 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.
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Active ingredients (in each caplet) Nighttime
- Purpose
-
Uses
temporarily relieves common cold/flu symptoms:
- •
- nasal congestion
- •
- sinus congestion and pressure
- •
- cough due to minor throat and bronchial irritation
- •
- cough to help you sleep
- •
- minor aches and pains
- •
- headache
- •
- fever
- •
- sore throat
- •
- runny nose and sneezing
- •
- reduces swelling of nasal passages
- •
- temporarily restores freer breathing through the nose
- •
- promotes nasal and/or sinus drainage
-
Warnings
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: Acetaminophen may cause severe skin reactions. Symptoms may include:
- •
- skin reddening
- •
- blisters
- •
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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
- •
- 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
Ask a doctor before use if you have
- •
- liver disease
- •
- heart disease
- •
- high blood pressure
- •
- thyroid disease
- •
- diabetes
- •
- glaucoma
- •
- cough that occurs with too much phlegm (mucus)
- •
- a breathing problem such as emphysema or chronic bronchitis
- •
- trouble urinating due to an enlarged prostate gland
- •
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
- •
- taking sedatives or tranquilizers
- •
- taking the blood thinning drug warfarin
When using this product
- •
- do not use more than directed
- •
- excitability may occur, especially in children
- •
- marked drowsiness may occur
- •
- avoid alcoholic drinks
- •
- be careful when driving a motor vehicle or operating machinery
- •
- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
- •
- you get nervous, dizzy or sleepless
- •
- pain, nasal congestion, or cough 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.
- Keep out of reach of children.
- Directions
- Other information
-
Inactive ingredients
crospovidone, D&C yellow #10 aluminum lake, FD&C blue #1 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow #6 aluminum lake, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
- Questions or comments?
-
Package/Label Principal Display Panel
Daytime Relief
Compare to Vicks® DayQuil® Severe+ VapoCOOL™ active ingredient
Non-Drowsy
Daytime Severe Cold & Flu
Acetaminophen
Phenylephrine HCl
Dextromethorphan HBr
Guaifenesin
actual size
Pain Reliever/Fever Reducer
Nasal Decongestant
Cough Suppressant
Expectorant
Max Strength
32 CAPLETS
Vapor Ice™
Nighttime Relief
Compare to Vicks® NyQuil® Severe+ VapoCOOL™ active ingredient
Nighttime Severe Cold & Flu
Acetaminophen
Phenylephrine HCl
Doxylamine Succinate
Dextromethorphan HBr
actual size
Pain Reliever/Fever Reducer
Nasal Decongestant
Antihistamine
Cough Suppressant
Max Strength
16 CAPLETS
Vapor Ice™
-
INGREDIENTS AND APPEARANCE
BASIC CARE DAYTIME SEVERE COLD AND FLU NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride, doxylamine succinate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-502 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-502-72 1 in 1 CARTON; Type 0: Not a Combination Product 08/05/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 16 BLISTER PACK 32 Part 2 8 BLISTER PACK 16 Part 1 of 2 BASIC CARE DAYTIME SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride tablet, film coatedProduct Information Item Code (Source) NDC:72288-357 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MALTODEXTRIN (UNII: 7CVR7L4A2D) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color ORANGE Score no score Shape OVAL Size 19mm Flavor Imprint Code L35C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-357-00 2 in 1 BLISTER PACK; 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 Part 2 of 2 BASIC CARE NIGHTTIME SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride tablet, film coatedProduct Information Item Code (Source) NDC:72288-721 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 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 HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength CROSPOVIDONE (120 .MU.M) (UNII: 68401960MK) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C BLUE NO. 2 (UNII: L06K8R7DQK) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MAGNESIUM STEARATE (UNII: 70097M6I30) MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POVIDONE, UNSPECIFIED (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) STEARIC ACID (UNII: 4ELV7Z65AP) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color GREEN Score no score Shape OVAL Size 19mm Flavor Imprint Code L72V Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-721-00 2 in 1 BLISTER PACK; 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 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M012 08/05/2021 Labeler - Amazon.com Services LLC (128990418)