Antigrip Cold & Cough Gelcaps (apta)

Antigrip Cold & Cough Gelcaps (apta)
SPL v1
SPL
SPL Set ID 3b53e5fc-f258-c2b9-e063-6394a90ab500
Route
ORAL
Published
Effective Date 2025-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Chlorpheniramine (2 mg) Dextromethorphan (10 mg) Acetaminophen (325 mg)
Inactive Ingredients
Sorbitan Titanium Dioxide Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Sorbitol Water D&c Red No. 33

Identifiers & Packaging

Pill Appearance
Imprint: 610 Shape: capsule Color: blue Size: 11 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-08-01

Description

.

Purpose

.


Medication Information

Purpose

.

Description

.

Uses

Temporarily relieves common cough and cold symptoms due to

  • minor aches and pain
  • headache
  • runny nose
  • sneezing
  • minor throat and bronchial irritation
  • temporarily reduces fever
Section 55105-1
Active ingredients (in each gel Softgel) Purposes
Acetaminophen 325 mg ............

Pain reliever/ fever reducer

Chlorpheniramine maleate 2 mg ..........

Antihistamine
Dextromethorphan HBr 10 mg.......... Cough suppressant
Warnings

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

  • adult takes more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday 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.

Directions
  • take each dose with plenty of water
Age Dose
Adults and children 12 years and older 2 softgels, every 6 hours not to exceed 4 doses in 24 hours
children 6 to under 12 years of age 1 softgel, every 4 hours not to exceed 5 doses in 24 hours
children under 6 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 prescription monoamine oxidase inhibitors (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.
Dist By/ Por:

PHARMADEL LLC

New Castle, DE 19720

Questions/ Preguntas? +1-866-359-3478

If Pregnant Or

ask a health professional before use.

Other Information
  • store between 68-77°F (20-25"C)
  • avoid excessive heat
Inactive Ingredients

D&C red #33, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water

Principal Display Panel

When Using This Product
  • may cause marked drowsiness
  • may cause excitability, especially in children
  • may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery
Stop Use and Ask A Doctor If
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • a cough comes back or occurs with a rash headache that lasts. These could be signs of a serious condition.
Active Ingredients & Purposes

.

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 the User

  • is a child with pain from arthritis
  • has liver disease
  • has glaucoma
  • has a breathing problem such as emphysema or chronic bronchitis
  • has difficulty in urination due to enlargement of the prostate gland
  • has a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • has a cough that is accompanied by excessive phlegm (mucus)
  • is taking sedatives or tranquilizers
Ask A Doctor Or Pharmacist Before Use If the User

is taking the blood thinning drug warfarin


Structured Label Content

Uses

Temporarily relieves common cough and cold symptoms due to

  • minor aches and pain
  • headache
  • runny nose
  • sneezing
  • minor throat and bronchial irritation
  • temporarily reduces fever
Section 55105-1 (55105-1)
Active ingredients (in each gel Softgel) Purposes
Acetaminophen 325 mg ............

Pain reliever/ fever reducer

Chlorpheniramine maleate 2 mg ..........

Antihistamine
Dextromethorphan HBr 10 mg.......... Cough suppressant
Warnings

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

  • adult takes more than 4 doses in 24 hours, which is the maximum daily amount for this product
  • child takes more than 5 doses in 24 hours
  • taken with other drugs containing acetaminophen
  • adult has 3 or more alcoholic drinks everyday 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.

Directions
  • take each dose with plenty of water
Age Dose
Adults and children 12 years and older 2 softgels, every 6 hours not to exceed 4 doses in 24 hours
children 6 to under 12 years of age 1 softgel, every 4 hours not to exceed 5 doses in 24 hours
children under 6 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 prescription monoamine oxidase inhibitors (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.
Dist By/ Por: (Dist by/ por:)

PHARMADEL LLC

New Castle, DE 19720

Questions/ Preguntas? +1-866-359-3478

If Pregnant Or (If pregnant or)

ask a health professional before use.

Other Information
  • store between 68-77°F (20-25"C)
  • avoid excessive heat
Inactive Ingredients

D&C red #33, FD&C blue #1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, sorbitol sorbitan solution, titanium dioxide, water

Principal Display Panel

When Using This Product (When using this product)
  • may cause marked drowsiness
  • may cause excitability, especially in children
  • may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • 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)
  • pain or cough gets worse or lasts more than 5 days (children) or 7 days (adults)
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • a cough comes back or occurs with a rash headache that lasts. These could be signs of a serious condition.
Active Ingredients & Purposes (Active ingredients & Purposes)

.

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 the User (Ask a doctor before use if the user)

  • is a child with pain from arthritis
  • has liver disease
  • has glaucoma
  • has a breathing problem such as emphysema or chronic bronchitis
  • has difficulty in urination due to enlargement of the prostate gland
  • has a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • has a cough that is accompanied by excessive phlegm (mucus)
  • is taking sedatives or tranquilizers
Ask A Doctor Or Pharmacist Before Use If the User (Ask a doctor or pharmacist before use if the user)

is taking the blood thinning drug warfarin


Advanced Ingredient Data


Raw Label Data

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