Tabcin Antigrip Softgel (hhh)(da)

Tabcin Antigrip Softgel (hhh)(da)
SPL v12
SPL
SPL Set ID 0670c33e-8a3c-ae00-e063-6294a90a165b
Route
ORAL
Published
Effective Date 2023-09-28
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (250 mg) Phenylephrine (5 mg) Chlorpheniramine (2 mg) Dextromethorphan (10 mg)
Inactive Ingredients
Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol 400 Povidone K30 Propylene Glycol Sorbitol Water Titanium Dioxide Methylparaben Propylparaben

Identifiers & Packaging

Pill Appearance
Imprint: SN5 Shape: capsule Color: blue Size: 21 mm
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2023-10-02 Until 2027-08-01

Description

Acetaminophen 250mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg

Purpose

Acetaminophen 250mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg


Medication Information

Purpose

Acetaminophen 250mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg

Description

Acetaminophen 250mg Chlorpheniramine maleate 2 mg Dextromethorphan hydrobromide 10 mg Phenylephrine hydrochloride 5 mg

Uses

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

  • runny nose
  • sneezing
  • cough due to minor bronchial irritation
  • nasal congestion
  • minor aches and pain
  • headache
  • sore throat
  • and to reduce fever
Section 55105-1

Active Ingredients Purposes
Acetaminophen 250mg................................... Pain reliever/ fever reducer
Chlorpheniramine maleate 2 mg.................... Antihistamine
Dextromethorphan hydrobromide 10 mg........ Cough suppressant
Phenylephrine hydrochloride 5 mg.................. Nasal decongestant

Warnings

Liver warning

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

  • more than 10 softgels 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.

Directions
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: 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 a doctor or pharmacist before taking this product.
Other Information
  • store at room temperature 15°-30°C (59°F-86°F)
  • avoid excessive heat
Inactive Ingredients

FD&C blue no.1, gelatin, glycerin, polyethylene glycol 400, povidone k30, propylene glycol, propylparaben, methylparaben, sodium hydroxide, sorbitol, titanium dioxide, water

Questions Or Comments

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

Principal Display Panel

When Using This Product
  • do not exceed the recommended dosage
  • 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
  • nervousness, dizziness, or sleeplessness occurs
  • the pain or cough gets worse or lasts 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.

Active Ingredients & Purposes

Acetaminophen 250mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

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 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
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor
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
  • cough due to minor bronchial irritation
  • nasal congestion
  • minor aches and pain
  • headache
  • sore throat
  • and to reduce fever
Section 55105-1 (55105-1)

Active Ingredients Purposes
Acetaminophen 250mg................................... Pain reliever/ fever reducer
Chlorpheniramine maleate 2 mg.................... Antihistamine
Dextromethorphan hydrobromide 10 mg........ Cough suppressant
Phenylephrine hydrochloride 5 mg.................. Nasal decongestant

Warnings

Liver warning

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

  • more than 10 softgels 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.

Directions
  • adults and children 12 years and over: take 2 softgels with water every 4 hours. Do not exceed 10 softgels in 24 hours or as directed by a doctor.
  • children under 12 years: 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 a doctor or pharmacist before taking this product.
Other Information (Other information)
  • store at room temperature 15°-30°C (59°F-86°F)
  • avoid excessive heat
Inactive Ingredients (Inactive ingredients)

FD&C blue no.1, gelatin, glycerin, polyethylene glycol 400, povidone k30, propylene glycol, propylparaben, methylparaben, sodium hydroxide, sorbitol, titanium dioxide, water

Questions Or Comments (Questions or comments)

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

Principal Display Panel

When Using This Product (When using this product)
  • do not exceed the recommended dosage
  • 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)
  • nervousness, dizziness, or sleeplessness occurs
  • the pain or cough gets worse or lasts 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.

Active Ingredients & Purposes

Acetaminophen 250mg

Chlorpheniramine maleate 2 mg

Dextromethorphan hydrobromide 10 mg

Phenylephrine hydrochloride 5 mg

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 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
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • 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) unless directed by a doctor
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


Raw Label Data

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