Antigrip Extra Strength Red Effervescent (v)

SPL v1

SPL

SPL Set ID 25a26adf-fd90-bf57-e063-6294a90a4073

Route

ORAL

Published

Effective Date 2024-08-20

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

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

Inactive Ingredients

Fd&c Red No. 40 Water Acesulfame Potassium Anhydrous Citric Acid Polysorbate 80 Silicon Dioxide Sucralose Povidone K30 Sodium Benzoate Sodium Bicarbonate Dimethicone

Identifiers & Packaging

Pill Appearance

Imprint: V2 Shape: round Color: pink Size: 24 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2024-11-01

Description

Active ingredients (in each tablet) Purposes A cetaminophen 325 mg................... Pain reliever/ fever reducer Chlorpheniramine maleate 2 mg ........... Antihistamine Phenylephrine HCl 5 mg ..................... Nasal decongestant

Medication Information

Description

Uses

For the temporary relief of symptoms due to the common cold/ flu:

runny nose
sneezing
nasal congestion
minor aches and pain
headache
and temporarily reduces fever

Section 55105-1

Active ingredients (in each tablet)	Purposes
Acetaminophen 325 mg...................	Pain reliever/ fever reducer
Chlorpheniramine maleate 2 mg ...........	Antihistamine
Phenylephrine HCl 5 mg .....................	Nasal decongestant

Warnings

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

more than 12 tablets in 24 hours, which is the maximum daily amount for this product
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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Dist. By:

Pharmadel LLC.

New Castle, DE 19720

Directions

■ adults and children 12 years of age and older: take two (2) tablets fully dissolved in a 4 oz glass of water every 4 hours. Do not exceed 12 tablets in 24 hours or as directed by a doctor.

■ children under 12 years of age: do no use

Do Not Use

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. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product

Other Information

each tablet contains: potassium 10mg, sodium 246mg
store below 77°F (25°C) and a dry place

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, FD&C red #40, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, strawberry flavor, sucralose, water.

Questions Or Comments?

+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principle Display Panel

When Using This Product

do not exceed the recommended dosage
may cause drowsiness
may cause excitability, especially in children
avoid alcoholic beverages while taking this product
use caution when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If

nervousness, dizziness, or sleeplessness occurs
pain or nasal congestion persists for more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out of Reach of Children.

In case of an accidental overdose, get medical help or contact a Poison Control Center right away. 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
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

Ask A Doctor Or Pharmacist Before Use If You Are

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

For the temporary relief of symptoms due to the common cold/ flu:

runny nose
sneezing
nasal congestion
minor aches and pain
headache
and temporarily reduces fever

Section 55105-1 (55105-1)

Active ingredients (in each tablet)	Purposes
Acetaminophen 325 mg...................	Pain reliever/ fever reducer
Chlorpheniramine maleate 2 mg ...........	Antihistamine
Phenylephrine HCl 5 mg .....................	Nasal decongestant

Warnings

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

more than 12 tablets in 24 hours, which is the maximum daily amount for this product
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.

Sore throat warning: If sore throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Dist. By: (Dist. by:)

Pharmadel LLC.

New Castle, DE 19720

Directions

■ adults and children 12 years of age and older: take two (2) tablets fully dissolved in a 4 oz glass of water every 4 hours. Do not exceed 12 tablets in 24 hours or as directed by a doctor.

■ children under 12 years of age: do no use

Do Not Use (Do not use)

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. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product

Other Information (Other information)

each tablet contains: potassium 10mg, sodium 246mg
store below 77°F (25°C) and a dry place

Inactive Ingredients (Inactive ingredients)

acesulfame potassium, anhydrous citric acid, FD&C red #40, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, strawberry flavor, sucralose, water.

Questions Or Comments? (Questions or comments?)

+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principle Display Panel

When Using This Product (When using this product)

do not exceed the recommended dosage
may cause drowsiness
may cause excitability, especially in children
avoid alcoholic beverages while taking this product
use caution when driving a motor vehicle or operating machinery

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

nervousness, dizziness, or sleeplessness occurs
pain or nasal congestion persists for more than 7 days
fever gets worse or lasts more than 3 days
redness or swelling is present
new symptoms occur

If Pregnant Or Breastfeeding, (If pregnant or breastfeeding,)

ask a health professional before use.

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

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
a breathing problem such as emphysema or chronic bronchitis
difficulty in urination due to enlargement of the prostate gland

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

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "FD&C RED NO. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "2", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACESULFAME POTASSIUM", "unii": "23OV73Q5G9", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ANHYDROUS CITRIC ACID", "unii": "XF417D3PSL", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SUCRALOSE", "unii": "96K6UQ3ZD4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM BICARBONATE", "unii": "8MDF5V39QO", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "325", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "DIMETHICONE", "unii": "92RU3N3Y1O", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "For the temporary relief of symptoms due to the common cold/ flu: runny nose sneezing nasal congestion minor aches and pain headache and temporarily reduces fever", "55105-1": "Active ingredients (in each tablet) Purposes A cetaminophen 325 mg................... Pain reliever/ fever reducer Chlorpheniramine maleate 2 mg ........... Antihistamine Phenylephrine HCl 5 mg ..................... Nasal decongestant", "Warnings": "Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 12 tablets in 24 hours , which is the maximum daily amount for this product 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. Sore throat warning: If sore throat is severe, persists for more than 2 days, and is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.", "Dist. by:": "Pharmadel LLC. New Castle, DE 19720", "Directions": "■ adults and children 12 years of age and older: take two (2) tablets fully dissolved in a 4 oz glass of water every 4 hours. Do not exceed 12 tablets in 24 hours or as directed by a doctor. ■ children under 12 years of age: do no use", "Do not use": "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. If you do not know if your prescription drug contains an MAOI, ask your doctor or pharmacist before taking this product", "Other information": "each tablet contains: potassium 10mg, sodium 246mg store below 77°F (25°C) and a dry place", "Inactive ingredients": "acesulfame potassium, anhydrous citric acid, FD&C red #40, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, strawberry flavor, sucralose, water.", "Questions or comments?": "+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com", "When using this product": "do not exceed the recommended dosage may cause drowsiness may cause excitability, especially in children avoid alcoholic beverages while taking this product use caution when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if": "nervousness, dizziness, or sleeplessness occurs pain or nasal congestion persists for more than 7 days fever gets worse or lasts more than 3 days redness or swelling is present new symptoms occur", "If pregnant or breastfeeding,": "ask a health professional before use.", "Keep out of reach of children.": "In case of an accidental overdose, get medical help or contact a Poison Control Center right away. 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 a breathing problem such as emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland", "Ask a doctor or pharmacist before use if you are": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:09.599944 · Updated: 2026-03-14T23:04:39.787858