FDA.reportPublic FDA data

Cold Medicine

Manufacturer
Allegiant Health
Effective date
2021-11-23
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:57:00

Label at a glance#

ProductCold Medicine
Active ingredientACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE
Label structure9 sections

Dosage and administration

  Do not use more than directed Adults and children 12 years of age and older : take 2 tablets every 4 to 6 hours Do not take more than 10 tablets in 24 hours Children under 12 years of age : do not use this product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325 mg
Chlorpheniramine maleate 2 mg
Phenylephrine HCl 5 mg

Purpose

OTC - PURPOSE SECTION

Pain reliever/fever reducer
Antihistamine
Nasal decongestant

Use(s)

INDICATIONS & USAGE SECTION

temporarily relieves

  • minor aches and pains
  • headaches
  • nasal congestion
  • sinus congestion & pressure
  • runny nose
  • sneezing

Warnings

WARNINGS SECTION

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

  • more than 10 tablets in 24 hours, which is the maximum 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 reactions. Symptoms may include:

  • skin reddening
  • blisters
  • rash
    If a skin reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • if you are allergic to acetaminophen
  • more than 10 days unless directed by a doctor
  • 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

  • with any other drug containing acetaminophen (prescription or nonprescription). If you are not

sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have

  • liver disease
  • heart disease
  • glaucoma
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if

OTC - ASK DOCTOR/PHARMACIST SECTION

  • are taking the blood thinning drug warfarin
  • are taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not use more than directed
  • excitability may occur, especially in children
  • may cause
  • drowsiness
  • alcohol, sedatives, and tranquilizers may increase drowsiness 
  • avoid alcoholic drinks
  • be careful when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • redness or swelling is present
  • new symptoms occur
  • you get nervous, dizzy, or sleepless
  • pain or nasal congestion gets worse or lasts for more than 7 days
  • fever gets worse or lasts for more than 3 days

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

  •  Do not use more than directed
  • Adults and children 12 years of age and older: take 2 tablets every 4 to 6 hours
    Do not take more than 10 tablets in 24 hours
  • Children under 12 years of age: do not use this product in children under 12 years
    of age; this will provide more than the recommended dose (overdose) and may cause
    liver damage.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature in a dry place
  • do not use if blister package is torn.

Inactive ingredients

INACTIVE INGREDIENT SECTION

corn starch, crospovidone, hypromellose, microcrystalline
cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Questions

OTC - QUESTIONS SECTION

1-888-952-0050 Monday through Friday 9 AM - 5 PM EST.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Cold CongestionCold Congestion

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine HCl 5 MG Oral TabletPSN6
1046781acetaminophen 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSCD6
1046781APAP 325 MG / chlorpheniramine maleate 2 MG / phenylephrine hydrochloride 5 MG Oral TabletSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CHLORPHENIRAMINE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69168-004-51Cold Medicine20 in 1 CARTONTABLET206

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-004COLD MEDICINE TABLET [ALLEGIANT HEALTH]6Current NDC, Legacy NDC, 1 package rows20231020_443fbc44-2c33-4316-ad31-dcc5a5aa8f52.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-00469168-004-51

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACETAMINOPHEN362O9ITL9DACTIB
CHLORPHENIRAMINE MALEATEV1Q0O9OJ9ZACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
STARCH, CORNO8232NY3SJIACT
CROSPOVIDONE2S7830E561IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POVIDONEFZ989GH94EIACT
STEARIC ACID4ELV7Z65APIACT

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold MedicineCOLD MEDICINEAllegiant Health443fbc44-2c33-4316-ad31-dcc5a5aa8f522021-11-23WarningsExact identifier
ndc (package): 69168-004-51
ndc (product): 69168-004
ndc11 (package): 69168000451
spl id: 1e175274-049d-41ae-bef0-2a243661be70
spl set id: 443fbc44-2c33-4316-ad31-dcc5a5aa8f52

Reported adverse events (FAERS/openFDA)#

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