COLDTAC ULTRA- acetaminophen 325mg, chlorpheniramine maleate 2mg, phenylephrine hcl 5mg tablet

COLDTAC ULTRA by

Drug Labeling and Warnings

COLDTAC ULTRA by is a Otc medication manufactured, distributed, or labeled by Healthlife of USA, Centurion Laboratories pvt. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

Temporarily relieves these additional symptoms of hay fever:

• itching of the nose or throat
• itchy, watery eyes
• helps clear nasal passages
• helps decongest sinus openings and passages

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. 

Keep out of reach of children

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

INGREDIENTS AND APPEARANCE

COLDTAC ULTRA 
acetaminophen 325mg, chlorpheniramine maleate 2mg, phenylephrine hcl 5mg tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69517-142
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE	5 mg

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
MALTODEXTRIN (UNII: 7CVR7L4A2D)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
STEARIC ACID (UNII: 4ELV7Z65AP)
STARCH, CORN (UNII: O8232NY3SJ)
POVIDONE (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69517-142-06	3 in 1 PACKAGE	10/02/2017
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 69517-142-72	36 in 1 PACKAGE	10/02/2017
2		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/02/2017

Labeler - Healthlife of USA (079656178)

Establishment
Name	Address	ID/FEI	Business Operations
Centurion Laboratories pvt. Ltd.		873229784	manufacture(69517-142) , analysis(69517-142) , pack(69517-142)