basic care nighttime severe cold and flu

acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hydrochloride · Solution · Oral

Over the counter Antihistamine Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist

Active ingredient

Active ingredients (in each 15 mL) Acetaminophen 325 mg Dextromethorphan HBr 10 mg Doxylamine Succinate 6.25 mg Phenylephrine HCl 5 mg

Purpose

Purpose Pain reliever/fever reducer Cough suppressant Antihistamine Nasal decongestant

Uses

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

Warnings Liver warning: This product contains acetaminophen. Severe liver damage may occur if
• adult takes more than 4,000 mg of acetaminophen in 24 hours
• child takes more than 5 doses in 24 hours
• taken with other drugs containing acetaminophen
• adult has 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.
• to make a child sleepy
• 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
• glaucoma
• thyroid disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema 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 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 5 days (children) or 7 days (adults)
• 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. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

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.
• to make a child sleepy
• if you have ever had an allergic reaction to this product or any of its ingredients

Ask a doctor before use

Ask a doctor before use if you have
• liver disease
• heart disease
• high blood pressure
• glaucoma
• thyroid disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• trouble urinating due to an enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• persistent or chronic cough such as occurs with smoking, asthma, or emphysema

Ask a doctor or pharmacist

Ask a doctor or pharmacist before use if you are
• taking the blood thinning drug warfarin
• taking sedatives or tranquilizers

When using this product

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

Stop use and ask a doctor if
• you get nervous, dizzy or sleepless
• pain, nasal congestion, or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
• 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.

Pregnancy or breast-feeding

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions

Directions
• take only as directed – see Overdose warning
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs adults & children 12 yrs & over 30 mL every 4 hrs children 6 to under 12 yrs 15 mL every 4 hrs children 4 to under 6 yrs ask a doctor children under 4 yrs do not use

Inactive ingredients

Inactive ingredients anhydrous citric acid, D&C yellow #10, edetate disodium, FD&C green #3, FD&C red #40, FD&C yellow #6, flavor, glycerin, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium benzoate, sodium chloride, sodium citrate, sorbitol solution, sucralose, xanthan gum

Questions?

Questions? 1-800-719-9260

Label text from the FDA structured product label by Amazon.com Services LLC (revised Nov 11, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

basic care nighttime severe cold and flu NDC products (4)

NDCStrength & formLabelerType
72288-189Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 20 mg/30mL; Doxylamine Succinate 12.5 mg/30mL; Phenylephrine…
Solution
Amazon.com Services LLCOTC MONOGRAPH DRUG
72288-601Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Doxylamine Succinate 6.25 mg/15mL; Phenylephrine…
Solution
Amazon.com Services LLCOTC MONOGRAPH DRUG
72288-639Acetaminophen 650 mg/30mL; Dextromethorphan Hydrobromide 20 mg/30mL; Doxylamine Succinate 12.5 mg/30mL; Phenylephrine…
Solution
Amazon.com Services LLCOTC MONOGRAPH DRUG
72288-721Acetaminophen 325 mg/1; Dextromethorphan Hydrobromide 10 mg/1; Doxylamine Succinate 6.25 mg/1; Phenylephrine…
Tablet, Film Coated
Amazon.com Services LLCOTC MONOGRAPH DRUG

Frequently asked questions

What is basic care nighttime severe cold and flu used for?

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

Who makes basic care nighttime severe cold and flu?

basic care nighttime severe cold and flu is listed by 1 labeler in the FDA NDC directory, including Amazon.com Services LLC.