Coldtac Plus Softgels

Acetaminophen, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride · Capsule, Liquid Filled · Oral

Over the counter Sigma-1 Agonist Uncompetitive N-methyl-D-aspartate Receptor Antagonist alpha-1 Adrenergic Agonist

Active ingredient

Drug Facts Active ingredients (in each Softgel) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant

Purpose

Active ingredients (in each Softgel) Purpose Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan HBr 10 mg Cough suppressant Phenylephrine HCl 5 mg Nasal decongestant

Uses

Uses Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches & pains Fever

Warnings

Warnings Liver warning This product contains acetaminophen. Severe liver damage may occur if you take: more than 4 doses in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks daily while using this product Allergy alert Acetaminophen may cause severe skin reactions. Symtoms 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, lasts for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a 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 Heart disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland Cough that occurs with too much phlegm (mucus) Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema. Ask a doctor or pharmacist before use if you are: T aking the blood thinning drug warfarin. When using this product, do not use more than directed. Stop use and ask a doctor if You get nervouz, dizzy or sleepless. Symptoms get worse or last more than 5 days (children) or 7 days (adults). Fever gets worse or lasts more than 3 days. Redness or swelling is present. New symtoms occur. Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition. Keep out of reach of children. If pregnant or breast-feeding, ask a health professional before use. Overdose warning Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well for children even if you do not notice any signs or symptoms.

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.

Ask a doctor before use

Ask a doctor before use if you have Liver disease Heart disease Diabetes High blood pressure Trouble urinating due to enlarged prostate gland Cough that occurs with too much phlegm (mucus) Persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis or emphysema.

Ask a doctor or pharmacist

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

When using this product

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

Stop use and ask a doctor

Stop use and ask a doctor if You get nervouz, dizzy or sleepless. Symptoms get worse or last more than 5 days (children) or 7 days (adults). Fever gets worse or lasts more than 3 days. Redness or swelling is present. New symtoms occur. Cough comes back, or occurs with rash or headache that lasts. These could be signs of a serious condition.

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.

Directions

Directions Take only as directed. Do not exceed 4 doses per 24 hrs. Adults & children 12 yrs & over 2 softgels with water every 4 hrs Children 4 to under 12 yrs Ask a doctor Children under 4 yrs Do not use

Other information

Other information Store at room temperature.

Inactive ingredients

Inactive ingredients FD&C Red No. 40, FD&C Yellow No. 6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol special, titanium dioxide.

Questions?

Questions? Call to free 619-600-5632 Monday throughFriday 9AM - 5PM EST

Label text from the FDA structured product label by OPMX LLC. (revised Apr 5, 2024). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Coldtac Plus Softgels NDC products (1)

NDCStrength & formLabelerType
69729-120Dextromethorphan Hydrobromide 10 mg/1; Acetaminophen 325 mg/1; Phenylephrine Hydrochloride 5 mg/1
Capsule, Liquid Filled
OPMX LLC.OTC MONOGRAPH DRUG

Frequently asked questions

What is Coldtac Plus Softgels used for?

Uses Temporarily relieves common cold/flu symptoms: Nasal congestion Cough due to minor throat & bronchial irritation Sore throat Headache Minor aches & pains Fever

Who makes Coldtac Plus Softgels?

Coldtac Plus Softgels is listed by 1 labeler in the FDA NDC directory, including OPMX LLC..