DailyMed - SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution

NDC Code(s): 21130-091-40
Packager: Safeway

Category: HUMAN OTC DRUG LABEL
DEA Schedule: None

Drug Label Information

Updated October 28, 2024

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Active ingredients (in each 15 mL)
Acetaminophen 325 mg - Dextromethorphan HBr 10 mg - Guaifenesin 200 mg - Phenylephrine HCl 5 mg

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Guaifenesin 200 mg

Phenylephrine HCl 5 mg
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Purpose
Pain reliever/fever reducer - Cough suppressant - Expectorant - Nasal decongestant

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant
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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 ...

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

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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 ...

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.

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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 ...

•

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

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

•

each 15 mL contains: sodium 6 mg

•

store at 20-25°C (68-77°F). Do not refrigerate.

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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 ...

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
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Questions?
1-800-719-9260

1-800-719-9260
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Package/Label Principal Display Panel
Signature care® Quality Guaranteed - Compare to Vicks® DayQuil® Severe active ingredients - Maximum Strength - Non-Drowsy - Daytime Severe - Cold & Flu Relief - ACETAMINOPHEN 325 mg - Pain Reliever, Fever ...

Signature care®

Quality Guaranteed

Compare to Vicks® DayQuil® Severe active ingredients

Maximum Strength

Non-Drowsy

Daytime Severe

Cold & Flu Relief

ACETAMINOPHEN 325 mg

Pain Reliever, Fever Reducer

DEXTROMETHORPHAN HBr 10 mg

Cough Suppressant

GUAIFENESIN 200 mg

Expectorant

PHENYLEPHRINE HCl 5 mg

Nasal Decongestant

ORIGINAL FLAVOR

ALCOHOL FREE

12 FL OZ (355 mL)

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INGREDIENTS AND APPEARANCE

Product Information

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Published Date (What is this?)	Version	Files
Oct 30, 2024	5 (current)	download
Feb 27, 2023	4	download
Oct 26, 2018	3	download
Jun 9, 2016	2	download
Feb 3, 2016	1	download

	RxCUI	RxNorm NAME	RxTTY
1	1369842	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution	PSN
2	1369842	acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution	SCD
3	1369842	acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution	SY
4	1369842	acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution	SY
5	1369842	APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution	SY

Label:
SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylep...
SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
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Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

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

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

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

Label: SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylep...SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionview full title

View Package Photos

Drug Label Info

Safety

Related Resources

More Info For This Drug

Drug Label Information

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

Stop use and ask a doctor if

If pregnant or breast-feeding,

Keep out of reach of children.

Find additional resources

Safety

Related Resources

More Info on this Drug

SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylep...SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionview full title

Number of versions: 5

SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylep...SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionview full title

SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylep...SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionview full title

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SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylep...SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solutionview full title

If this SPL contains inactivated NDCs listed by the FDA initiated compliance action, they will be specified as such.

Label:
SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylep...
SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
view full title

SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylep...
SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
view full title

SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylep...
SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
view full title

SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylep...
SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
view full title

SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylep...
SIGNATURE CARE NON DROWSY DAYTIME SEVERE COLD AND FLU RELIEF- acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl solution
view full title