Cold and Chest Congestion Relief

Manufacturer
Discount Drug Mart | AptaPharma Inc.
Effective date
2017-04-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-02 01:16:58

Label at a glance#

ProductCold and Chest Congestion Relief
Active ingredientACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, GUAIFENESIN
Label structure17 sections

Indications and uses

temporarily relieves minor aches and pains sore throat headache nasal and sinus congestion temporarily reduces fever helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

Dosage and administration

take only as recommended (see Overdose warning) use dose cup or tablespoon (TBSP) do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor Age                              Dose Children under              Do not use 12 years of age Adults & children 12       2 tablespoonful years and over              30 mL every 4 hours

Label contents#

Full prescribing information#

Drug FactsActive ingredients(in each tablespoonful, 15 mL)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Guaifenesin 200 mg
Phenylephrine HCL 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliver/Fever reducer
Expectorant
Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

temporarily relieves

  • minor aches and pains
  • sore throat
  • headache
  • nasal and sinus congestion
  • temporarily reduces fever
  • helps loosen phlegm (mucus) and thin bronchial secretions to drain bronchial tubes and make cough more productive

Warnings

WARNINGS SECTION

Liver warning This product contains acetaminophen.

Severe liver damage may occur if you take:

  • more than 6 doses in 24 hours, which is the maxium daily amount
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin. 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

OTC - DO NOT USE SECTION

  • 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.f 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

OTC - ASK DOCTOR SECTION

  • 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, emphysema
  • cough that occurs with too much phlegm (mucus)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Overdose warning

OVERDOSAGE SECTION

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 noitce any signs or symptoms.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take only as recommended (see Overdose warning)
  • use dose cup or tablespoon (TBSP)
  • do not take more than 5 doses (150 mL) in 24 hours unless directed by a doctor

Age                              Dose
Children under              Do not use
12 years of age

Adults & children 12       2 tablespoonful
years and over              30 mL every 4 hours

Other information

OTHER SAFETY INFORMATION

  • each tablespoonful (15 mL) contains: sodium 10 mg, potassium 9 mg
  • dosage cup provided
  • store between 20-25°C (68-77°F)
  • do not refrigerate

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acesulfame potassium, anhydrous citric acid, edetate disodium, FD&C Yellow # 6, flavor, maltitol solution, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions?

OTC - QUESTIONS SECTION

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

Cold & Chest Congestion Relief product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DISCOUNT
drug
mart
FOOD FAIR

*COMPARE TO THE ACTIVE INGREDIENTS IN THERAFLU® WARMING RELIEF COLD & CHEST COMGETION

LF-016

Cold & Chest Congestion Relief

Acetaminophen ....................Pain Reliever /Fever Reducer
Guaifenesin .................Expectorant
Phenylephrine HCL ................Nasal Decongestant

  • Thins & Loosens Mucus
  • Nasal & Chest Congestion
  • Sore Throat
  • Body Ache
  • Headache
  • Fever

ORANGE FLAVOR

8.3 FL OZ (245 mL)

DO NOT USE IF PRINTED SEAL UNDER CAP IS TORN OR MISSING
Failure to follow these warnings could result in serious consequences

* This product is not manufactured or distributed by Novartis Consumer Health Inc., owner of the registered trademark Theraflu® Cold & Chest Congestion.

SATISFACTION GUARANTEED

IF DISSATISFIED, RETURN THE UNUSED PORTION AND PACKAGE TO THE STORE WHERE PURCHASED. IF UNABLE TO RETURN TO STORE, SEND REASON FOR DISSATISFACTION, NAME, ADDRESS, AND EMPTY PACKAGE TO: DISCOUNT DRUG MART, 211 COMMERCE DRIVE, MEDINIA, OHIO 44256

LB-016

Lot:
Exp:

AptaPharmDD ColdChest 521AptaPharmDD ColdChest 521

AptaPharmDD ColdChest 521 1AptaPharmDD ColdChest 521 1

AptaPharmDD ColdChest 521 2AptaPharmDD ColdChest 521 2

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53943-52153943-521-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4c821a77-a392-4c05-9bb6-bf34b11e6cb358aae233-c0ff-4e5e-9cda-451563d7212e2022-12-16WarningsExact identifier
spl set id: 58aae233-c0ff-4e5e-9cda-451563d7212e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.