Label: BASIC CARE NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride solution
- NDC Code(s): 0113-7501-40
- Packager: L. Perrigo Company
- 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 13, 2020
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- Active ingredients (in each 30 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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- 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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- cough due to minor throat and bronchial irritation
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- cough to help you sleep
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- reduces swelling of nasal passages
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- promotes nasal and/or sinus drainage
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- temporarily restores freer breathing through the nose
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
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- more than 4,000 mg of acetaminophen in 24 hours
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- with other drugs containing acetaminophen
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- 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.
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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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- if you have ever had an allergic reaction to this product or any of its ingredients
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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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- thyroid disease
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- diabetes
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- glaucoma
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- cough that occurs with too much phlegm (mucus)
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- a breathing problem such as emphysema or chronic bronchitis
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- trouble urinating due to an enlarged prostate gland
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- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
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- a sodium-restricted diet
- Ask a doctor or pharmacist before use if you are
- When using this product
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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 7 days
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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.
- Keep out of reach of children.
- Directions
- Other information
- Inactive ingredients
- Questions or comments?
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
BASIC CARE NIGHTTIME COLD AND FLU
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0113-7501 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 650 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 20 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 10 mg in 30 mL Inactive Ingredients Ingredient Name Strength ALCOHOL (UNII: 3K9958V90M) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) D&C YELLOW NO. 10 (UNII: 35SW5USQ3G) EDETATE DISODIUM (UNII: 7FLD91C86K) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0113-7501-40 355 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/25/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 02/25/2020 Labeler - L. Perrigo Company (006013346)