Antigrip Flu Blue Effervescent (v)

Antigrip Flu Blue Effervescent (v)
SPL v1
SPL
SPL Set ID 25a23a03-6110-f595-e063-6394a90a70fe
Route
ORAL
Published
Effective Date 2024-08-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (5 mg) Acetaminophen (325 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Water Acesulfame Potassium Anhydrous Citric Acid Polysorbate 80 Povidone K30 Sodium Benzoate Sucralose Sodium Bicarbonate Dimethicone Silicon Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: V1 Shape: round Color: white 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 Dextromethorphan HBr 10 mg ........... Cough suppressant Phenylephrine HCl 5 mg ..................... Nasal decongestant


Medication Information

Description

Active ingredients (in each tablet) Purposes A cetaminophen 325 mg................... Pain reliever/ fever reducer Dextromethorphan HBr 10 mg ........... Cough suppressant Phenylephrine HCl 5 mg ..................... Nasal decongestant

Uses

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

  • cough due to minor bronchial irritation
  • nasal congestion
  • minor aches and pains
  • headache
  • and temporarily reduces fever
Section 55105-1
Active ingredients (in each tablet) Purposes
Acetaminophen 325 mg...................

Pain reliever/ fever reducer

Dextromethorphan HBr 10 mg ........... Cough suppressant
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.

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 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
  • each tablet contains: potassium 10mg, sodium 274mg
  • store below 77° F(25° C) and in a dry place
Inactive Ingredients

acesulfame potassium, anhydrous citric acid, lemon flavor, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, 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
Stop Use and Ask A Doctor If
  • nervousness, dizziness, or sleeplessness occurs
  • pain, cough, 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
  • cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition.
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
  • difficulty in urination due to enlargement of the prostate gland
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin

Structured Label Content

Uses

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

  • cough due to minor bronchial irritation
  • nasal congestion
  • minor aches and pains
  • headache
  • and temporarily reduces fever
Section 55105-1 (55105-1)
Active ingredients (in each tablet) Purposes
Acetaminophen 325 mg...................

Pain reliever/ fever reducer

Dextromethorphan HBr 10 mg ........... Cough suppressant
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.

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 not 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 274mg
  • store below 77° F(25° C) and in a dry place
Inactive Ingredients

acesulfame potassium, anhydrous citric acid, lemon flavor, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, 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
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • nervousness, dizziness, or sleeplessness occurs
  • pain, cough, 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
  • cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition.
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.)

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 (Ask a doctor before use if you have)
  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus)
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

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)