FDA Label for Coldtac Ultra
View Indications, Usage & Precautions
- DRUG FACTS
- PURPOSE
- USES
- WARNINGS
- ALLERGY ALERT
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- OVERDOSE WARNING
- DIRECTIONS: DO NOT TAKE MORE THAN DIRECTED (SEE OVERDOSE WARNING)
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS? 619-600-5632
- COLDTAC ULTRA2 TABLETS IN A POUCH
Coldtac Ultra 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.
Drug Facts
ACTIVE INGREDIENTS:
Acetaminophen USP 325mg........................................Pain reliever
Chlorpheniramine Maleate USP 2mg.............................Antihistamine
Phenylephrine HCL USP 5mg.......................................Nasal decongestant
Purpose
Pain reliever
Antihistamine
Nasal decongestant
Uses
Tempporarily relieves these symptoms of hay fever or other upper respiratory allergies:
- headache
- sinus congestion and pressure
- nasal congestion
- runny nose and sneezing
- minor aches and pains
- itching of the nose or throat
- itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus openings and passages
Temporarily relieves these additional symptoms of hay fever:
Warnings
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing 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
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 dugs 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 a MAOI, ask a doctor or pharmacist before taking this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
- to make a child sleepy
Ask A Doctor Before Use If You Have
liver disease, heart disease, high blood pressure, thyroid disease, diabetes, trouble urinating due to an enlarged prostate gland, a breathing problem such as emphysema or chronic bronchitis, glaucoma
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children
- drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- new symptoms occur
- nervousness, dizziness, or sleeplessness occur
- pain or nasal congestion gets worse or last more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present.
- These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Overdose Warning
in case of overdose, get medical help or contact a Poison Control Center right away (844) 832-1138. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions: Do Not Take More Than Directed (See Overdose Warning)
Adults and children 12 years and over:
- take 2 tablets every 4-6 hours
- swallow whole - do not crush, chew or dissolve
- do not take more than 12 tablets in 24 hours
Children under 12 years: ask a doctor
Other Information
- Tamper evident. do not use if packet is torn, cut or opened
- Store at controlled room temperature 15° to 30°C (59° to 86°F)
- Avoid excessive heat and humidity
Inactive Ingredients
hydroxypropyl methylcellulose, methylcellulose, maltodextrin, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, starch, stearic acid
Questions Or Comments? 619-600-5632
(Mon-Fri 9am - 5pm EST) or https://www/facebook.com/republikrx/
The carton has the complete information.
Coldtac Ultra2 Tablets In A Pouch
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