Coldtac Plus - Softgels

Coldtac Plus - Softgels
SPL v2
SPL
SPL Set ID ff5ce5c6-a03f-2ad3-e053-6394a90a99f6
Route
ORAL
Published
Effective Date 2022-05-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Dextromethorphan (10 mg) Acetaminophen (325 mg) Phenylephrine (5 mg)
Inactive Ingredients
Fd&c Yellow No. 6 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol, Unspecified Povidone Propylene Glycol Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: AP01 Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-06-30

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses

Temporarily relieves common cold/flu symptoms:

  • Nasal congestion
  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches & pains
  • Fever
Section 42229-5

Made for:



RRX



Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

Section 50565-1

Keep out of reach of children.

Section 50568-5

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

Section 55105-1
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
Section 55106-9

Drug Facts

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
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.
Questions?

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

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.
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
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.

Other Information
  • Store at room temperature.
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.

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.

Principal Display Panel

NDC 69729-120-10

Coldtac Plus

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5mg

Pain reliever, fever reducer/ Fiebre y cuerpo cortado

Nasal Descongestant/ Descongestivo nasal

Cough Suppressant/ Supresor de la tos

Contents/Content

10 Softgels/ Capsulas de Gel

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.
If Pregnant Or Breast Feeding,

ask a health professional 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.

Structured Label Content

Uses

Temporarily relieves common cold/flu symptoms:

  • Nasal congestion
  • Cough due to minor throat & bronchial irritation
  • Sore throat
  • Headache
  • Minor aches & pains
  • Fever
Section 42229-5 (42229-5)

Made for:



RRX



Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

Section 50565-1 (50565-1)

Keep out of reach of children.

Section 50568-5 (50568-5)

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

Section 55105-1 (55105-1)
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
Section 55106-9 (55106-9)

Drug Facts

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
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.
Questions?

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

Allergy Alert (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.
Liver Warning (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
Overdose Warning (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.

Other Information (Other information)
  • Store at room temperature.
Sore Throat Warning (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.

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 69729-120-10

Coldtac Plus

Acetaminophen 325 mg

Dextromethorphan HBr 10 mg

Phenylephrine HCl 5mg

Pain reliever, fever reducer/ Fiebre y cuerpo cortado

Nasal Descongestant/ Descongestivo nasal

Cough Suppressant/ Supresor de la tos

Contents/Content

10 Softgels/ Capsulas de Gel

When Using This Product, (When using this product,)

do not use more than directed.

Stop Use and Ask A Doctor If (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.
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have (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.

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)