FDA Label for Coldtac Plus Softgels
View Indications, Usage & Precautions
- OTC - ACTIVE INGREDIENT
- OTC - PURPOSE
- USES
- LIVER WARNING
- ALLERGY ALERT
- SORE THROAT WARNING
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- OTC - ASK DOCTOR/PHARMACIST
- WHEN USING THIS PRODUCT,
- STOP USE AND ASK A DOCTOR IF
- OTC - KEEP OUT OF REACH OF CHILDREN
- IF PREGNANT OR BREAST-FEEDING,
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- OTHER
- PRINCIPAL DISPLAY PANEL
Coldtac Plus Softgels Product Label
The following document was submitted to the FDA by the labeler of this product Opmx Llc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Drug Facts
Otc - 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
Temporarily relieves common cold/flu symptoms:
- Nasal congestion
- Cough due to minor throat & bronchial irritation
- Sore throat
- Headache
- Minor aches & pains
- Fever
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.
Otc - Ask Doctor/Pharmacist
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
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
Other
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
* Please review the disclaimer below.