Grandall (as Pld) - Sanaflu Xtra (48201-001)

Grandall (as Pld) - Sanaflu Xtra (48201-001)
SPL v10
SPL
SPL Set ID 4af8a566-5251-4d46-8692-87a3a0748334
Route
ORAL
Published
Effective Date 2015-04-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Phenylephrine (5 mg) Acetaminophen (250 mg) Chlorpheniramine (2 mg)
Inactive Ingredients
Methylparaben Sodium Propylparaben Sodium Water D&c Red No. 33 Fd&c Blue No. 1 Gelatin Glycerin Polyethylene Glycol 600 Polyethylene Glycol 1000 Propylene Glycol

Identifiers & Packaging

Pill Appearance
Imprint: none Shape: oval Color: blue Size: 24 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-04-30

Description

Acetaminophen 250 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Purpose

Pain reliever - fever reducer Antihistamine Cough Suppressant Nasal Decongestant


Medication Information

Purpose

Pain reliever - fever reducer Antihistamine Cough Suppressant Nasal Decongestant

Description

Acetaminophen 250 mg Chlorpheniramine maleate 2 mg Dextromethorphan HBr 10 mg Phenylephrine HCl 5 mg

Uses
  • Temporarily relives
  • minor aches and pains
  • headache
  • runny nose
  • sneezing
  • nasal congestion
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • itching of the nose or throat
  • cough due to minor throat and bronchial irritation as may occur with the common cold ro inhaled irritants
  • Temperarily reduces fever
Purposes

Pain reliever - fever reducer

Antihistamine

Cough Suppressant

Nasal Decongestant

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product.
Directions
  • Adults and children 12 years of age and older: Take 2 capsules every 4 hours; not more than 12 capsules in 24 hours.
  • Children under 12 years of age: Consult a doctor.
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 monamine 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.
Package Labeling

Other Information
  • Store at room temperature in a dry place.
Inactive Ingredients

D&C Red 33, FD&C Blue 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, polyvinylpyrrolidone, propylene glycol, sodium methylparaben, sodium propylparaben, water

When Using This Product
  • do not use more than directed
  • may cause marked drowsiness
  • alcohol, sedativies, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • may cause excitability, especially in children.
Stop Use and Ask A Doctor If
  • pain, cough, or nasal congestion 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 rash or headache that lasts. These could be signs of a serious condition.
  • nervousness, dizziness, or sleeplessness occur.
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 critial even if you do not notice any signs or symptoms.

Ask A Doctor Before Use If You Have
  • liver disease
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • persistant or chrnoic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm
  • thyroid disease
  • diabetes
Active Ingredients (in Each Capsule)

Acetaminophen 250 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

Ask A Doctor Or Pharmacist Before Use If You Are
  • taking the blood thinning drug warfarin
  • taking sedativies or tranquilizers

Structured Label Content

Uses
  • Temporarily relives
  • minor aches and pains
  • headache
  • runny nose
  • sneezing
  • nasal congestion
  • itchy, watery eyes due to hay fever or other upper respiratory allergies
  • itching of the nose or throat
  • cough due to minor throat and bronchial irritation as may occur with the common cold ro inhaled irritants
  • Temperarily reduces fever
Purposes

Pain reliever - fever reducer

Antihistamine

Cough Suppressant

Nasal Decongestant

Warnings

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

  • more than 4,000 mg of acetaminophen in 24 hours
  • with other drugs containing acetaminophen
  • 3 or more alcoholic drinks every day while using this product.
Directions
  • Adults and children 12 years of age and older: Take 2 capsules every 4 hours; not more than 12 capsules in 24 hours.
  • Children under 12 years of age: Consult a doctor.
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 monamine 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.
Package Labeling

Other Information (Other information)
  • Store at room temperature in a dry place.
Inactive Ingredients (Inactive ingredients)

D&C Red 33, FD&C Blue 1, gelatin, glycerin, polyethylene glycol 600, polyethylene glycol 1000, polyvinylpyrrolidone, propylene glycol, sodium methylparaben, sodium propylparaben, water

When Using This Product (When using this product)
  • do not use more than directed
  • may cause marked drowsiness
  • alcohol, sedativies, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages
  • use caution when driving a motor vehicle or operating machinery
  • may cause excitability, especially in children.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • pain, cough, or nasal congestion 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 rash or headache that lasts. These could be signs of a serious condition.
  • nervousness, dizziness, or sleeplessness occur.
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 critial 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
  • a breathing problem such as emphysema or chronic bronchitis
  • glaucoma
  • heart disease
  • high blood pressure
  • difficulty in urination due to enlargement of the prostate gland
  • persistant or chrnoic cough such as occurs with smoking, asthma, or emphysema
  • cough accompanied by excessive phlegm
  • thyroid disease
  • diabetes
Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))

Acetaminophen 250 mg

Chlorpheniramine maleate 2 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5 mg

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 sedativies or tranquilizers

Advanced Ingredient Data


Raw Label Data

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