Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Phenylephrine (5 mg) Chlorpheniramine (2 mg)

Inactive Ingredients

D&c Yellow No. 10 Fd&c Yellow No. 6 Hypromellose 2910 (15 Cps) Triacetin Povidone Stearic Acid Cellulose, Microcrystalline

Identifiers & Packaging

Pill Appearance

Imprint: PAC Shape: capsule Color: yellow Size: 17 mm Score: 1

Marketing Status

OTC MONOGRAPH FINAL Active Since 2010-02-03

Medication Information

Dosage and Administration

Directions

Adults: Take 1 to 2 caplets with water every 6 hours as needed; do not take more than 8 caplets in 24 hours or as directed by a doctor.

Description

Active Ingredients (in each caplet) Acetaminophen 500 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg

Section 51727-6

Enter section text here

Section 53413-1

Questions? 1-904-367-8437, Monday-Friday, 9am-5pm EST

Section 55105-1

Purposes

Pain reliever/Fever Reducer

Antihistamine

Nasal Decongestant

Section 55106-9

Active Ingredients (in each caplet)

Acetaminophen 500 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Warnings

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

more than 8 caplets in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Hybrid Cf

aada0b4d-1776-48e5-98e2-a2e769279c5a.jpg

Do Not Use

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 product containing any of the above active ingredients.

with any other drug containing acetaminophen (prescription or nonprescription).

Ask a doctor or pharmacist before using with other drugs if you are not sure.

When Using This Product

do not use more than directed

excitability may occur, especially in children

drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives and tranquilizers may increase the drowsiness

use caution when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

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

If Pregnant Or Breast Feeding

ask a health professional before use.

Keep Out of Reach of Children

In case of overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
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

you are taking sedatives or tranquilizers.

Structured Label Content

Dosage and Administration (34068-7)

Directions

Adults: Take 1 to 2 caplets with water every 6 hours as needed; do not take more than 8 caplets in 24 hours or as directed by a doctor.

Section 51727-6 (51727-6)

Enter section text here

Section 53413-1 (53413-1)

Questions? 1-904-367-8437, Monday-Friday, 9am-5pm EST

Section 55105-1 (55105-1)

Purposes

Pain reliever/Fever Reducer

Antihistamine

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients (in each caplet)

Acetaminophen 500 mg

Chlorpheniramine maleate 2 mg

Phenylephrine HCl 5 mg

Warnings

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

more than 8 caplets in 24 hours

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.

Hybrid Cf (Hybrid CF)

aada0b4d-1776-48e5-98e2-a2e769279c5a.jpg

Do Not Use

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 product containing any of the above active ingredients.

with any other drug containing acetaminophen (prescription or nonprescription).

Ask a doctor or pharmacist before using with other drugs if you are not sure.

When Using This Product (When using this product)

do not use more than directed

excitability may occur, especially in children

drowsiness may occur

avoid alcoholic drinks

alcohol, sedatives and tranquilizers may increase the drowsiness

use caution when driving a motor vehicle or operating machinery

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

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

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)

In case of overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

liver disease
heart disease
high blood pressure
thyroid disease
diabetes
glaucoma
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 (Ask a doctor or pharmacist before use if)

you are taking sedatives or tranquilizers.

Advanced Ingredient Data

[{"name": "D&C YELLOW NO. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C YELLOW NO. 6", "unii": "H77VEI93A8", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYPROMELLOSE 2910 (15 CPS)", "unii": "36SFW2JZ0W", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TRIACETIN", "unii": "XHX3C3X673", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE", "unii": "FZ989GH94E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STEARIC ACID", "unii": "4ELV7Z65AP", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CELLULOSE, MICROCRYSTALLINE", "unii": "OP1R32D61U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIM", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIM", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIM", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"34068-7": "Directions Adults: Take 1 to 2 caplets with water every 6 hours as needed; do not take more than 8 caplets in 24 hours or as directed by a doctor.", "51727-6": "Enter section text here", "53413-1": "Questions? 1-904-367-8437, Monday-Friday, 9am-5pm EST", "55105-1": "Purposes Pain reliever/Fever Reducer Antihistamine Nasal Decongestant", "55106-9": "Active Ingredients (in each caplet) Acetaminophen 500 mg Chlorpheniramine maleate 2 mg Phenylephrine HCl 5 mg", "Warnings": "Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 8 caplets in 24 hours with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Alcohol warning: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take acetaminophen or other pain relievers/fever reducers. Acetaminophen may cause liver damage.", "Hybrid CF": "aada0b4d-1776-48e5-98e2-a2e769279c5a.jpg", "Do Not Use": "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 product containing any of the above active ingredients. with any other drug containing acetaminophen (prescription or nonprescription). Ask a doctor or pharmacist before using with other drugs if you are not sure.", "When using this product": "do not use more than directed excitability may occur, especially in children drowsiness may occur avoid alcoholic drinks alcohol, sedatives and tranquilizers may increase the drowsiness use caution when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "you get nervous, dizzy or sleepless redness of swelling is present new symptoms occur symptoms get worse or last for more than 7 days fever gets worse or lasts more than 3 days", "If pregnant or breast feeding": "ask a health professional before use.", "Keep out of reach of children": "In case of overdose, get medical help or contact a Poison Control Center immediately. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.", "Ask a doctor before use if you have": "liver disease heart disease high blood pressure thyroid disease diabetes glaucoma 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": "you are taking sedatives or tranquilizers."}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information