DAYTIME SEVERE- acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

daytime severe by

Drug Labeling and Warnings

daytime severe by is a Otc medication manufactured, distributed, or labeled by CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients (in each 15 mL)

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

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

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
• diabetes
• thyroid disease
• 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.

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

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

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?

1-800-719-9260

Package/Label Principal Display Panel

CVS Health®

Compare to the active ingredients in Vicks® DayQuil® Severe Honey Flavor

Daytime Severe

ACETAMINOPHEN

Pain reliever; Fever reducer

DEXTROMETHORPHAN HBr

Cough suppressant

GUAIFENESIN

Expectorant

PHENYLEPHRINE HCl

Nasal decongestant

Relieves:

Headache, Fever, Sore throat, Minor aches & pains, Chest congestion, Nasal & Sinus congestion, Sinus pressure, Cough

Thins & loosens mucus

COLD & FLU

Honey Flavor

ANTIHISTAMINE FREE

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

DAYTIME SEVERE 
acetaminophen, dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51316-613
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
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 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)

Product Characteristics
Color	YELLOW	Score
Shape		Size
Flavor	HONEY, MENTHOL	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51316-613-40	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	06/28/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	06/28/2023

Labeler - CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED (062312574)