Greenfield - Cold Medicine

SPL v6

SPL

SPL Set ID 443fbc44-2c33-4316-ad31-dcc5a5aa8f52

Route

ORAL

Published

Effective Date 2021-11-23

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (325 mg) Chlorpheniramine (2 mg) Phenylephrine (5 mg)

Inactive Ingredients

Starch, Corn Crospovidone Hypromellose, Unspecified Microcrystalline Cellulose Polyethylene Glycol, Unspecified Povidone Stearic Acid

Identifiers & Packaging

Pill Appearance

Imprint: AZ275 Shape: round Color: white Size: 11 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2021-11-12

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever/fever reducer Antihistamine Nasal decongestant

Medication Information

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Description

Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg

Use(s)

temporarily relieves

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

Warnings

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.

Questions

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

Directions

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.

Do Not Use

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.

Other Information

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

Active Ingredient(s)

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Inactive Ingredients

corn starch, crospovidone, hypromellose, microcrystalline

cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Pregnancy/breastfeeding

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

Principal Display Panel

Cold Congestion

When Using This Product

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

Ask A Doctor Before Use If

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

Stop Use and Ask A Doctor If

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

Keep Out of Reach of Children

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.

Ask A Doctor Or Pharmacist Before Use If

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

Structured Label Content

Use(s)

temporarily relieves

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

Purpose

Pain reliever/fever reducer

Antihistamine

Nasal decongestant

Warnings

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.

Questions

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

Directions

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.

Do Not Use (Do not use)

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.

Other Information (Other information)

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

Active Ingredient(s) (Active ingredient(s))

Acetaminophen 325 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Inactive Ingredients (Inactive ingredients)

corn starch, crospovidone, hypromellose, microcrystalline

cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid

Pregnancy/breastfeeding (Pregnancy/Breastfeeding)

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

Principal Display Panel

Cold Congestion

When Using This Product (When using this product)

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

Ask A Doctor Before Use If (Ask a doctor before use if)

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

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

Keep Out of Reach of Children (Keep out of reach of children)

Ask A Doctor Or Pharmacist Before Use If (Ask a doctor or pharmacist before use if)

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

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use(s)": "temporarily relieves minor aches and pains headaches nasal congestion sinus congestion & pressure runny nose sneezing", "Purpose": "Pain reliever/fever reducer Antihistamine Nasal decongestant", "Warnings": "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.", "Questions": "1-888-952-0050 Monday through Friday 9 AM - 5 PM EST.", "Directions": " 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.", "Do not use": "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.", "Other information": "store at room temperature in a dry place do not use if blister package is torn.", "Active ingredient(s)": "Acetaminophen 325 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg", "Inactive ingredients": "corn starch, crospovidone, hypromellose, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid", "Pregnancy/Breastfeeding": "If pregnant or breast-feeding, ask a health professional before use.", "Principal Display Panel": "Cold Congestion", "When using this product": "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", "Ask a doctor before use if": "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", "Stop use and ask a doctor if": "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", "Keep out of reach of children": "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.", "Ask a doctor or pharmacist before use if": "are taking the blood thinning drug warfarin are taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:01:26.029448 · Updated: 2026-03-14T23:01:25.991637