Label: BASIC CARE NIGHTTIME SEVERE COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride solution
- NDC Code(s): 72288-601-40
- Packager: Amazon.com Services 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 April 22, 2022
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 15 mL)
- Purpose
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Uses
temporarily relieves common cold/flu symptoms:
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- nasal congestion
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- sinus congestion and pressure
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- cough due to minor throat and bronchial irritation
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- cough to help you sleep
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- minor aches and pains
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- headache
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- fever
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- sore throat
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- runny nose and sneezing
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- reduces swelling of nasal passages
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- temporarily restores freer breathing through the nose
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- promotes nasal and/or sinus drainage
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
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- adult takes more than 4,000 mg of acetaminophen in 24 hours
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- child takes more than 5 doses in 24 hours
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- taken with other drugs containing acetaminophen
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- adult has 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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- skin reddening
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- blisters
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- 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
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- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
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- 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.
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- to make a child sleepy
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- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
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- liver disease
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- heart disease
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- high blood pressure
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- glaucoma
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- thyroid disease
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- diabetes
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- cough that occurs with too much phlegm (mucus)
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- trouble urinating due to an enlarged prostate gland
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- a breathing problem such as emphysema or chronic bronchitis
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
Ask a doctor or pharmacist before use if you are
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- taking the blood thinning drug warfarin
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- taking sedatives or tranquilizers
When using this product
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- do not use more than directed
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- excitability may occur, especially in children
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- marked drowsiness may occur
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- avoid alcoholic drinks
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- be careful when driving a motor vehicle or operating machinery
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- alcohol, sedatives, and tranquilizers may increase drowsiness
Stop use and ask a doctor if
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- you get nervous, dizzy or sleepless
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- pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
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- fever gets worse or lasts more than 3 days
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- redness or swelling is present
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- new symptoms occur
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- cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
- Directions
- Other information
- Inactive ingredients
- Questions?
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Package/Label Principal Display Panel
amazon
basic care
Multi-Symptom Relief
Compare to Vicks® NyQuil® Severe Honey Flavor active ingredients
Nighttime Severe Cold & Flu
Acetaminophen, Phenylephrine HCl, Dextromethorphan HBr, Doxylamine Succinate
Pain Reliever, Fever Reducer, Nasal Decongestant, Cough Suppressant, Antihistamine
Max Strength
Honey Flavor
12 FL OZ (355 mL)
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INGREDIENTS AND APPEARANCE
BASIC CARE NIGHTTIME SEVERE COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-601 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C GREEN NO. 3 (UNII: 3P3ONR6O1S) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM CHLORIDE (UNII: 451W47IQ8X) SODIUM CITRATE, UNSPECIFIED FORM (UNII: 1Q73Q2JULR) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) XANTHAN GUM (UNII: TTV12P4NEE) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:72288-601-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/22/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 04/22/2022 Labeler - Amazon.com Services LLC (128990418)
