COLDTAC ULTRA- acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet

COLDTAC ULTRA by

Drug Labeling and Warnings

COLDTAC ULTRA by is a Otc medication manufactured, distributed, or labeled by OPMX LLC, Vovantis Laboratories Private Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS (in each tablet)

Acetaminophen 500 mg

Chlorpheniramine Maleate 4 mg

Phenylephrine HCl 10 mg

PURPOSE

PURPOSE

Pain Reliever/Fever Reducer

Antihistamine

Nasal decongestant

INDICATIONS & USAGE

Uses:

• temporarily relieves these symptoms of hay fever or other respiratory allergies:
• headache
• sinus congestion & pressure
• nasal congestion
• runny nose and sneezing
• minor aches & pain
• temporarily relieves these additional symptoms of hay fever:
• nose or throat itching
• itchy, watery eyes
• helps clear nasal passages
• helps decongest sinus opening and passages

WARNINGS

Warnings

Liver warning:This product contains acetaminophen. Severe liver damage may occur if you take :

• more than 6 tablets in 24 hours, which is the maximum daily amount for this product
• with other drugs contains 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.

Sore throat warning:if sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult 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.
• 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
• glaucoma
• diabetes
• trouble urinating due to enlarged prostate gland
• a breathing problem such as emphysema or chronic bronchitis

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 use more than directed
• 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:

• nervousness, dizziness, or sleeplessness occur
• pain or nasal congestion gets worse or lasts more than 7 days
• fever gets worse or last more than 3 days
• redness or swelling is present
• new symptoms occur

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:Taking more than directed can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions:

• Do not take more than directed - see overdose warning
• Swallow whole; do not crush, chew or dissolve
• Do not exceed 6 tablets per 24 hours

• Adults and children 12 years of age & over: 1 tablet with water every 4-6 hours as needed
• Children 4 to 12 years of age: Ask a doctor
• Children under 4 years of age: Do not use

STORAGE AND HANDLING

Other information:

• Store at room temperature between 20-25°C (68-77ºF)
• Avoid excessive heat and humidity

INACTIVE INGREDIENT

Inactive ingredients:magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

QUESTIONS

Questions or comments?

Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us

SPL UNCLASSIFIED SECTION

TAMPER EVIDENT: DO NOT USE IF POUCH IS TORN, BROKEN OR SHOWS ANY SIGN OF TAMPERING

Exclusively distributed by:

OPMX

San Diego, CA 92154

Phone: 619-600-5632

PRINCIPAL DISPLAY PANEL - 144 TABLETS

NDC: 69729-133-38

COLDTAC ULTRA

Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg

Effective and Quick Relief from Cold & Flu Symptoms

Headache

Fever

Body Aches

Sneezing

Runny Nose

Watery Eye

Nasal Congestion

Sore Throat​

​144 Tablets (72 Packs of 2 tablets)

PRINCIPAL DISPLAY PANEL - 12 TABLETS

NDC: 69729-133-38

COLDTAC ULTRA

Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg

Effective and Quick Relief from Cold & Flu Symptoms

Headache

Fever

Body Aches

Sneezing

Runny Nose

Watery Eye

Nasal Congestion

Sore Throat​

​12 Tablets (6 Packs of 2 tablets)

PRINCIPAL DISPLAY PANEL - 6 TABLETS

NDC: 69729-133-06

COLDTAC ULTRA

Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg

Effective and Quick Relief from Cold & Flu Symptoms

Headache

Fever

Body Aches

Sneezing

Runny Nose

Watery Eye

Nasal Congestion

Sore Throat​

​6 Tablets (3 Packs of 2 tablets)

PRINCIPAL DISPLAY PANEL - 2 TABLETS

NDC: 69729-133-27

COLDTAC ULTRA

Actaminophen 500 mg, Chlorpheniramine Maleate 4 mg, Phenylephrine HCl 10 mg

Effective and Quick Relief from Cold & Flu Symptoms

Headache

Fever

Body Aches

Sneezing

Runny Nose

Watery Eye

Nasal Congestion

Sore Throat​

​2 Tablets

INGREDIENTS AND APPEARANCE

COLDTAC ULTRA 
acetaminophen, chlorpheniramine maleate, phenylephrine hcl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 69729-133
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	10 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	4 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SODIUM STARCH GLYCOLATE TYPE A (UNII: H8AV0SQX4D)
TALC (UNII: 7SEV7J4R1U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	13mm
Flavor		Imprint Code	A15
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 69729-133-38	72 in 1 CARTON	01/10/2024
1		2 in 1 POUCH; Type 0: Not a Combination Product
2	NDC: 69729-133-37	6 in 1 CARTON	01/10/2024
2		2 in 1 POUCH; Type 0: Not a Combination Product
3	NDC: 69729-133-06	3 in 1 CARTON	01/10/2024
3		2 in 1 POUCH; Type 0: Not a Combination Product
4	NDC: 69729-133-27	2 in 1 POUCH; Type 0: Not a Combination Product	01/10/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	01/10/2024

Labeler - OPMX LLC (029918743)

Establishment
Name	Address	ID/FEI	Business Operations
Vovantis Laboratories Private Limited		650502151	manufacture(69729-133)