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Generic: acetaminophen, dextromethorphan hydrobromide, phenylephrine hydrochloride is used for the treatment of Cough Fever Glucosephosphate Dehydrogenase Deficiency Liver Diseases Pain Fissure in Ano Glaucoma, Open-Angle Hemorrhoids Hypertension Hypotension Pruritus Ani Rhinitis, Vasomotor Shock, Septic Tachycardia, Supraventricular Mydriasis Tachycardia, Ventricular


IMPRINT: AP01     SHAPE: oval
    COLOR: red

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Otc - Active Ingredient Section


Drug Facts

Otc - Active Ingredient Section


OTC - PURPOSE SECTION

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


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

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 bulers
  • 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.

OTC - ASK DOCTOR/PHARMACIST SECTION


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 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


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.

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

  • Store at room temperature.

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?


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


Made for: RRX Exclusively distributed by:

OPMX

Chula Vista, CA 91910

Phone: 619-600-5632

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



DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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