Coldtac Severe

Coldtac Severe
SPL v4
SPL
SPL Set ID 9a164cfc-b623-9a9f-e053-2a95a90a0173
Route
ORAL
Published
Effective Date 2019-02-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Guaifenesin (200 mg) Dextromethorphan (10 mg) Phenylephrine (5 mg)
Inactive Ingredients
Polyethylene Glycol 400 Glycerin Water Food Yellow 3 Free Acid Propylene Glycol Sorbitol Povidone K30 Gelatin Sorbitan

Identifiers & Packaging

Pill Appearance
Imprint: 782 Shape: oval Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-18

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Guaifenesin 200mg Phenylephrine HCl 5mg


Medication Information

Warnings and Precautions

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs contains 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult doctor promptly

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.

Ask a doctor before use if you have:

Liver disease

High blood pressure

Thyroid disease

Diabetes

Trouble urinating due to enlarged prostate gland

Cough that occurs with too much phlegm (mucus)

Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if:

You get nervous, dizzy, or sleepless

Pain, nasal congestion, or cough gets worse or lasts more than 7 days

Fever gets worse or last 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.

If pregnant or breast-feeding: ask a health professional before use.

Keep out of reach of children.

Indications and Usage

Temporarily relieves common cold/flu symptoms:

  • Nasal congestion
  • Sinus congestion & pressure
  • Cough due to minor throat & bronchial irritation
  • Minor aches & pain
  • Headache
  • Fever
  • Sore throat
  • Reduces swelling of nasal passages
  • Temporarily restore freer breathing through the nose
  • Promotes nasal and/or sinus drainage
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Dosage and Administration

  • Take only as directed (See overdose warning)
  • Do not exceed 4 doses per 24-hours
  • Adults and children 12 years and over: take 2 softgels with water every 4 hours
  • Children 4 to under 12 years: ask a doctor
  • When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Description

Acetaminophen 325mg Dextromethorphan HBr 10mg Guaifenesin 200mg Phenylephrine HCl 5mg

Section 34088-5

OVERDOSE WARNING: Read directions carefully. 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.

Section 50565-1

Keep out of reach of children.

Section 51727-6

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Section 51945-4

Section 55105-1

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Guaifenesin 200mg

Phenylephrine HCl 5mg

Section 60561-8

store at room temperature between 20-25°C (68-77ºF)

avoid excessive heat and humidity


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves common cold/flu symptoms:

  • Nasal congestion
  • Sinus congestion & pressure
  • Cough due to minor throat & bronchial irritation
  • Minor aches & pain
  • Headache
  • Fever
  • Sore throat
  • Reduces swelling of nasal passages
  • Temporarily restore freer breathing through the nose
  • Promotes nasal and/or sinus drainage
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.
Dosage and Administration (34068-7)

  • Take only as directed (See overdose warning)
  • Do not exceed 4 doses per 24-hours
  • Adults and children 12 years and over: take 2 softgels with water every 4 hours
  • Children 4 to under 12 years: ask a doctor
  • When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

Warnings and Precautions (34071-1)

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses in 24 hours, which is the maximum daily amount for this product with other drugs contains 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, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult doctor promptly

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.

Ask a doctor before use if you have:

Liver disease

High blood pressure

Thyroid disease

Diabetes

Trouble urinating due to enlarged prostate gland

Cough that occurs with too much phlegm (mucus)

Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if:

You get nervous, dizzy, or sleepless

Pain, nasal congestion, or cough gets worse or lasts more than 7 days

Fever gets worse or last 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.

If pregnant or breast-feeding: ask a health professional before use.

Keep out of reach of children.

Section 34088-5 (34088-5)

OVERDOSE WARNING: Read directions carefully. 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.

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 51727-6 (51727-6)

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

Section 55106-9 (55106-9)

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Guaifenesin 200mg

Phenylephrine HCl 5mg

Section 60561-8 (60561-8)

store at room temperature between 20-25°C (68-77ºF)

avoid excessive heat and humidity


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Raw Label Data

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