Coldtac Severe
9a164cfc-b623-9a9f-e053-2a95a90a0173
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
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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Source: dailymed · Ingested: 2026-02-15T12:03:06.279079 · Updated: 2026-03-14T23:02:58.626725