Pancold A Oral Solution

Pancold A Oral Solution
SPL v15
SPL
SPL Set ID fc8f1807-d344-ccc2-e053-6294a90a5089
Route
ORAL
Published
Effective Date 2023-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Pentoxyverine (15 mg) Acetaminophen (32.4 mg) Guaifenesin (10 mg) Chlorpheniramine (300 mg) Caffeine (80 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Sodium Citrate Sucralose Propylene Glycol Citric Acid Monohydrate Edetate Disodium Alcohol Saccharum Officinarum Stem Fructooligosaccharides Water Orange Lemon

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-01 Until 2028-06-04

Description

Active ingredients (in each 30 mL bottle) Acetaminophen 300 mg Guaifenesin 80 mg Pentoxyverine citrate 15 mg Phenylephrine Hydrochloride 10 mg Chlorpheniramine maleate 2.5 mg Caffeine 30 mg

Purpose

Pain Reliever-Fever Reducer, Expectorant, Antitussive, Nasal Decongestant, Antihistamine, Pain reliever aid

Storage and Handling

Other nformation store at room temperature between 15°-25°C (59°-77°F) and avoid direct sunlight


Medication Information

Purpose

Pain Reliever-Fever Reducer, Expectorant, Antitussive, Nasal Decongestant, Antihistamine, Pain reliever aid



Storage and Handling

Other nformation

  • store at room temperature between 15°-25°C (59°-77°F) and avoid direct sunlight
Description

Active ingredients (in each 30 mL bottle) Acetaminophen 300 mg Guaifenesin 80 mg Pentoxyverine citrate 15 mg Phenylephrine Hydrochloride 10 mg Chlorpheniramine maleate 2.5 mg Caffeine 30 mg

Section 51945-4

Stop Use

Stop use and ask doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion or cough gets worse or last more than 7 days
  • fever gets worse or lasts more than 3 days n redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Do Not Use

Do not use

  • if you ever had an allergic reaction to this product or any of its ingredients
  • with any other drug containing acetaminophen. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If you are 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 MAOI, ask a doctor or pharmacist before taking this product.
  • If you are taking expectorants, other cold drugs, antipyretic-analgesics, sedatives, oral drugs containing antihistamines (oral drugs for rhinitis, motion sickness drugs, and allergy drugs)
Overdosage

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptom.

Ask A Doctor

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarge prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
  • glaucoma (eye pain, blurred vision)
  • weak body
  • high fever
Warnings Section

Warnings

Liver Warning: This 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 glasses of alcohol everyday while using this product

Allergy alert: acetaminophen mat 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Active Ingredients

Active ingredients (in each 30 mL bottle)

  • Acetaminophen 300 mg
  • Guaifenesin 80 mg
  • Pentoxyverine citrate 15 mg
  • Phenylephrine Hydrochloride 10 mg
  • Chlorpheniramine maleate 2.5 mg
  • Caffeine 30 mg
Indications & Usage

Uses temporarily relieves these common cold symptoms:

  • runny nose & sneezing
  • nasal congestion
  • sore throat
  • cough
  • phlegm
  • chills
  • fever
  • headache
  • joint pain
  • muscle pain
Inactive Ingredients
  • Inactive Ingredients: : alcohol, citric acid monohydrate, edetate disodium, fructooligosaccharide, lemon flavor, orange flavor, propylene glycol, sodium citrate, sucralose, water
Dosage & Administration

Directions

  • do not take more than directed (see overdose warning)
Adults: Take 1 bottle (30mL) three times a day, 30 minutes after meal.
Children and infants: Do not administer. Ask a doctor.

Pregnancy 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.


Structured Label Content

Section 51945-4 (51945-4)

Purpose (PURPOSE)

Pain Reliever-Fever Reducer, Expectorant, Antitussive, Nasal Decongestant, Antihistamine, Pain reliever aid



Stop Use (STOP USE)

Stop use and ask doctor if

  • nervousness, dizziness, or sleeplessness occur
  • pain, nasal congestion or cough gets worse or last more than 7 days
  • fever gets worse or lasts more than 3 days n redness or swelling is present
  • cough comes back or occurs with rash or headache that lasts

These could be signs of a serious condition.

Do Not Use (DO NOT USE)

Do not use

  • if you ever had an allergic reaction to this product or any of its ingredients
  • with any other drug containing acetaminophen. If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
  • If you are 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 MAOI, ask a doctor or pharmacist before taking this product.
  • If you are taking expectorants, other cold drugs, antipyretic-analgesics, sedatives, oral drugs containing antihistamines (oral drugs for rhinitis, motion sickness drugs, and allergy drugs)
Overdosage (OVERDOSAGE)

Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptom.

Ask A Doctor (ASK A DOCTOR)

Ask a doctor before use if you have

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • trouble urinating due to enlarge prostate gland
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema
  • cough that occurs with too much phlegm (mucus)
  • glaucoma (eye pain, blurred vision)
  • weak body
  • high fever
Warnings Section (WARNINGS SECTION)

Warnings

Liver Warning: This 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 glasses of alcohol everyday while using this product

Allergy alert: acetaminophen mat 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Active Ingredients (ACTIVE INGREDIENTS)

Active ingredients (in each 30 mL bottle)

  • Acetaminophen 300 mg
  • Guaifenesin 80 mg
  • Pentoxyverine citrate 15 mg
  • Phenylephrine Hydrochloride 10 mg
  • Chlorpheniramine maleate 2.5 mg
  • Caffeine 30 mg
Indications & Usage (INDICATIONS & USAGE)

Uses temporarily relieves these common cold symptoms:

  • runny nose & sneezing
  • nasal congestion
  • sore throat
  • cough
  • phlegm
  • chills
  • fever
  • headache
  • joint pain
  • muscle pain
Inactive Ingredients (INACTIVE INGREDIENTS)
  • Inactive Ingredients: : alcohol, citric acid monohydrate, edetate disodium, fructooligosaccharide, lemon flavor, orange flavor, propylene glycol, sodium citrate, sucralose, water
Storage and Handling (STORAGE AND HANDLING)

Other nformation

  • store at room temperature between 15°-25°C (59°-77°F) and avoid direct sunlight
Dosage & Administration (DOSAGE & ADMINISTRATION)

Directions

  • do not take more than directed (see overdose warning)
Adults: Take 1 bottle (30mL) three times a day, 30 minutes after meal.
Children and infants: Do not administer. Ask a doctor.

Pregnancy Or Breast Feeding (PREGNANCY 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)

Keep out of reach of children.


Advanced Ingredient Data


Raw Label Data

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