Active Ingredients (In Each Caplet) Daytime
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
The following Structured Product Label (SPL) was submitted to the FDA by Amazon.com Services Llc for the product Basic Care Nighttime Severe Cold And Flu (NDC 72288-721). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredients (in each caplet) daytime, purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Guaifenesin 200 mg
Phenylephrine HCl 5 mg
Pain reliever/fever reducer
Cough suppressant
Expectorant
Nasal decongestant
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
temporarily relieves common cold/flu symptoms:
temporarily relieves common cold/flu symptoms:
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
if you have ever had an allergic reaction to this product or any of its ingredients
if you have ever had an allergic reaction to this product or any of its ingredients
persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
persistent or chronic cough such as occurs with smoking, asthma, or emphysema
taking the blood thinning drug warfarin
taking the blood thinning drug warfarin
do not use more than directed
alcohol, sedatives, and tranquilizers may increase drowsiness
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
ask a health professional before use.
ask a health professional before use.
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.
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.
adults & children 12 yrs & over | 2 caplets with water every 4 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
adults & children 12 yrs & over | 2 caplets with water every 4 hrs |
children 4 to under 12 yrs | ask a doctor |
children under 4 yrs | do not use |
croscarmellose sodium, crospovidone, FD&C yellow #6 aluminum lake, flavor, maltodextrin, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, silicon dioxide, stearic acid, sucralose, talc, titanium dioxide
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
1-800-719-9260
1-800-719-9260
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCl 5 mg
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