Cold & Sinus 515

Cold & Sinus 515
SPL v2
SPL
SPL Set ID 6e5ca8e1-5a03-4e77-b385-d44387fb3bfc
Route
ORAL
Published
Effective Date 2017-04-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (650 mg) Guaifenesin (400 mg) Phenylephrine (10 mg)
Inactive Ingredients
Anhydrous Citric Acid Edetate Disodium Fd&c Blue No. 1 Fd&c Red No. 40 Glycerin Propylene Glycol Propyl Gallate Water Sodium Benzoate Sorbitol Sucralose Xanthan Gum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-09-19

Description

Acetaminophen 650 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg

Purpose

Pain reliever/Fever reducer Expectorant Nasal decongestant


Medication Information

Purpose

Pain reliever/Fever reducer

Expectorant

Nasal decongestant

Description

Acetaminophen 650 mg Guaifenesin 400 mg Phenylephrine HCL 10 mg

Uses

temporarily relieves these common cold and flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • sore throat
  • headache
  • fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Warnings

Liver warning This product contains acetamnophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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.

Directions
  • take only as recommended (see Overdose warning)
  • use dosage cup
  • mL = milliliter
  • do not take more han 6 doses in any 24-hour period

Age                                                  Dose

Adults & children                               20 mL every 4 hours

12 years and older

Children under 12                             Do not use

years of age

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.
  • for children under 12 years of age
Drug Facts

Acetaminophen 650 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944

Overdose Warning

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information
  • each 20 mL contains: sodium 10 mg
  • dosage cup provided
  • store between 15-30 C (59-86 F)
  • do not refrigerate
Inactive Ingredients

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

When Using This Product
  • do not use more that directed
Cold and Sinus Product Label

Market Basket®

"MORE FOR YOUR MONEY"

* COMPARE TO

the active ingredients found in

MUCINEX® FAST-MAX™

COLD & SINUS

Cold & Sinus

MAXIUN STRENGTH

Acetaminophen



(Pain Reliever/Fever Reducer)

Guiafenesin (Expectorant)

Phenylephrine HCL

(Nasal Decongestant)

Relieves Fever & Body Aches

Thins & Loosens Mucus

Relieves Nasal & Chest Congestion

Adults For Ages 12 & Over

LF-009 Rev 01

6 FL OZ (177 mL)

Peel Corner to Read Completed Drug Facts and information

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Failure to follow these warnings could result in serious consequences.

DISTRIBUTED BY

DEMOULAS SUPERMARKETS INC.

875 East Street

TEWKSBURY, MA 01876

* This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Mucinex® FAST-MAX™ COLD & SINUS

Stop Use and Ask A Doctor If
  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistant headache. 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.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning product warfarin.

Structured Label Content

Uses

temporarily relieves these common cold and flu symptoms:

  • nasal congestion
  • sinus congestion and pressure
  • minor aches and pains
  • sore throat
  • headache
  • fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes
Purpose

Pain reliever/Fever reducer

Expectorant

Nasal decongestant

Warnings

Liver warning This product contains acetamnophen. Severe liver damage may occur if you take:

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 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.

Directions
  • take only as recommended (see Overdose warning)
  • use dosage cup
  • mL = milliliter
  • do not take more han 6 doses in any 24-hour period

Age                                                  Dose

Adults & children                               20 mL every 4 hours

12 years and older

Children under 12                             Do not use

years of age

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.
  • for children under 12 years of age
Drug Facts

Acetaminophen 650 mg

Guaifenesin 400 mg

Phenylephrine HCL 10 mg

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST 1-877-798-5944

Overdose Warning (Overdose warning)

Taking more than the recommended dose (overdose) may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Other Information (Other information)
  • each 20 mL contains: sodium 10 mg
  • dosage cup provided
  • store between 15-30 C (59-86 F)
  • do not refrigerate
Inactive Ingredients (Inactive ingredients)

anhydrous citric acid, edetate disodium, FD&C Blue #1, FD&C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

When Using This Product (When using this product)
  • do not use more that directed
Cold and Sinus Product Label (Cold and Sinus product label)

Market Basket®

"MORE FOR YOUR MONEY"

* COMPARE TO

the active ingredients found in

MUCINEX® FAST-MAX™

COLD & SINUS

Cold & Sinus

MAXIUN STRENGTH

Acetaminophen



(Pain Reliever/Fever Reducer)

Guiafenesin (Expectorant)

Phenylephrine HCL

(Nasal Decongestant)

Relieves Fever & Body Aches

Thins & Loosens Mucus

Relieves Nasal & Chest Congestion

Adults For Ages 12 & Over

LF-009 Rev 01

6 FL OZ (177 mL)

Peel Corner to Read Completed Drug Facts and information

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING

Failure to follow these warnings could result in serious consequences.

DISTRIBUTED BY

DEMOULAS SUPERMARKETS INC.

875 East Street

TEWKSBURY, MA 01876

* This product is not manufactured or distributed by Reckitt Benckiser Inc. distributor of Mucinex® FAST-MAX™ COLD & SINUS

Stop Use and Ask A Doctor If (stop use and ask a doctor if)
  • nervousness, dizziness or sleeplessness occur
  • redness or swelling is present
  • symptoms do not get better within 7 days or are accompanied by a fever
  • fever gets worse or lasts more than 3 days
  • new symptoms occur
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or persistant headache. These could be signs of a serious condition.
If Pregnant 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.)

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • thyroid disease
  • high blood pressure
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem or chronic cough that lasts or as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning product warfarin.

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