Severe Daytime

acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl · Solution · Oral

Over the counter Expectorant 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 Guaifenesin 200 mg Phenylephrine HCl 5 mg

Purpose

Purpose Pain reliever/fever reducer Cough suppressant Expectorant Nasal decongestant

Uses

Uses temporarily relieves common cold/flu symptoms:
• sinus congestion and pressure
• nasal congestion
• minor aches and pains
• headache
• sore throat
• fever
• cough due to minor throat and bronchial irritation
• reduces swelling of nasal passages
• promotes nasal and/or sinus drainage
• temporarily restores freer breathing through the nose
• helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive

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.
• 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
• cough that occurs with too much phlegm (mucus)
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin When using this product do not use more than directed 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.
• 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
• thyroid disease
• diabetes
• cough that occurs with too much phlegm (mucus)
• trouble urinating due to an enlarged prostate gland
• persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist

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

When using this product

When using this product do not use more than directed

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

Other information

Other information
• each 15 mL contains: sodium 6 m
• store at 20-25°C (68-77°F). Do not refrigerate.

Inactive ingredients

Inactive ingredients butylated hydroxyanisole, edetate disodium, FD&C yellow #6, flavor, glycerin, menthol, monobasic sodium phosphate, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sucrose, xanthan gum

Questions?

Questions? 1-800-719-9260

Label text from the FDA structured product label by CVS Pharmacy (revised Oct 28, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Severe Daytime NDC products (1)

NDCStrength & formLabelerType
59779-603Acetaminophen 325 mg/15mL; Dextromethorphan Hydrobromide 10 mg/15mL; Guaifenesin 200 mg/15mL; Phenylephrine…
Solution
CVS PharmacyOTC MONOGRAPH DRUG

Frequently asked questions

What is Severe Daytime used for?

Uses temporarily relieves common cold/flu symptoms: • sinus congestion and pressure • nasal congestion • minor aches and pains • headache • sore throat • fever • cough due to minor throat and bronchial irritation • reduces swelling of nasal passages • promotes nasal and/or sinus drainage • temporarily restores freer breathing through the nose • helps loosen phlegm (mucus) and thin bronchial…

Who makes Severe Daytime?

Severe Daytime is listed by 1 labeler in the FDA NDC directory, including CVS Pharmacy.