Cold, Flu and Sore Throat description, usages, side effects, indications, overdosage, supplying and lots more!

Cold, Flu and Sore Throat

DeMoulas Market Basket
AptaPharma Inc.

  • Description
  • Clinical Pharmacology
  • Indications & Usage
  • Contraindications
  • Warnings
  • Precautions
  • Side Effects
  • Overdosage
  • Dosage & Administration
  • How Supplied
  • Patient Counseling Information
  • Supplemental Patient Material
  • Boxed Warning
  • Patient Package Insert

FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Active ingredients

Drug Facts

Active ingredients  (in each 20 mL)

Acetaminophen 650 mg
Dextromethorphan HBr 20 mg
Guaifensin 400 mg
Phenylephrine HCL 10 mg


Purpose

Pain reliever/Fever reducer
Cough suppressant
Expectorant
Nasal decongestant

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.

Uses

temporarily relieves these common cold and flu symptoms:

  • cough due to minor throat and bronchial irritation
  • 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 acetaminophen. Sever 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 daily while using this product

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 drugs 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

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
  • persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis or emphysema
  • cough that occurs with too much phlegm (mucus)

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

  • 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 persistent headache. These could be signs of a serious condition.

If pregnant or breast feeding

ask a health professional before use

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.

Directions

Age - Adults and children 12 years and older       Dose - 20 mL every 4 hours

Age - Children under 12 years of age                  Dose - Do not use

    take only as recommended (see overdose warning)
    use dose cup
    mL = milliliter
    do not take more than 6 doses in any 24-hour period

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 and C Blue  #1, FD and C Red #40, flavors, glycerin, propylene glycol, propyl gallate, purified water, sodium benzoate, sorbitol, sucralose, Xanthan gum

Questions?

Call weekdays from 9:30 AM to 4:30 PM EST at

1-877-798-5944

Product Label

"MORE FOR YOUR DOLLAR"

MARKET BASKET
*COMPARE TO THE INGREDIENTS IN MUCINEX® FAST-MAX COLD™, FLU AND SORE THROAT


Cold, Flu and Sore Throat

Maximum Strength

Acetaminophen
Pain Reliever/Fever Reducer

Dextromethorophan HBr
Cough Suppressent

Guaifenesin Expectorant

Phenylephrine HCL
Nasal Decongestant


Relieves Fever and Body aches
Controls Cough
Thins and Loosens Mucus
Relieves Nasal and Chest Congestion

6 FL OZ (177mL)

Adults
For Ages 12 and Over

*This product is not manufactures or distributed bt Reckitt Benckiser Inc., distributor of Mucinex® FAST-MAX™ Cold, Flu and Sore Throat.
Peel Corner to Read Complete Drug Facts and Information

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

Failure to follow these warnings could result in consequences

DISTRIBUTED BY
DEMOULAS SUPERMARKETS INC.
875 East Street
Tewksbury, MA 01876

LB-008

Lot:
Exp:


Product Label


Product Label


Product Label

Product Label

Cold, Flu and Sore Throat

ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE LIQUID

Product Information

Product Type Human otc drug label Item Code (Source) NDC:53942-516
Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
ACETAMINOPHEN ACETAMINOPHEN 650 mg
DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN 20 mg
Guaifenesin GUAIFENESIN 400 mg
Phenylephrine Hydrochloride PHENYLEPHRINE 10 mg

Inactive Ingredients

Ingredient Name Strength
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

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:53942-516-25 177 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
part part341 2013-09-19


PLEASE, BE CAREFUL!
Be sure to consult your doctor before taking any medication!
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