Coldtac Ultra Tabs

SPL v4

SPL

SPL Set ID b373a3a8-68c4-0187-e053-2995a90aad62

Route

ORAL

Published

Effective Date 2019-08-26

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Acetaminophen (500 mg) Chlorpheniramine (4 mg) Phenylephrine (10 mg)

Inactive Ingredients

Sodium Benzoate Sodium Starch Glycolate Type A Potato Talc Silicon Dioxide Magnesium Stearate Starch, Corn Povidone K30

Identifiers & Packaging

Pill Appearance

Imprint: S78 Shape: round Color: white Size: 13 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Completed Since 2019-08-26 Until 2022-10-24

Description

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Chlorpheniramine Maleate 4 mg Antihistamine Phenylephrine HCl 10 mg Nasal decongestant

Purpose

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Chlorpheniramine Maleate 4 mg Antihistamine Phenylephrine HCl 10 mg Nasal decongestant

Medication Information

Purpose

Active ingredients (in each caplet)	Purpose
Acetaminophen 500 mg	Pain reliever
Chlorpheniramine Maleate 4 mg	Antihistamine
Phenylephrine HCl 10 mg	Nasal decongestant

Description

Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Chlorpheniramine Maleate 4 mg Antihistamine Phenylephrine HCl 10 mg Nasal decongestant

Uses

Temporarily relieves these symptoms of hay fever or other respiratory allergies:

headache
nasal congestion
sinus congestion & pressure
runny nose and sneezing
minor aches & pain

Temporarily relieves these additional symptoms of hay fever:

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

Section 50565-1

Keep out of reach of children.

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

Do Not Use

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen,
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
if you have ever had an allergic reaction to this product or any of its ingredients.
to make a child sleepy

Coldtac Ultra

NDC 69729-122-06

NDC 69729-122-37

NDC 69729-122-38

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.

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.

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.

Other Information

Store at room temperature between 20-25°C (68-77ºF)
Tamper evident: Do not use if pouch is torn, broken or shows any sing of tampering

Inactive Ingredients

magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

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

Questions Or Comments?

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

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 alcohol drinks
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If:

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough 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.

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 Ot Pharmacist If You Are:

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Structured Label Content

Uses

Temporarily relieves these symptoms of hay fever or other respiratory allergies:

headache
nasal congestion
sinus congestion & pressure
runny nose and sneezing
minor aches & pain

Temporarily relieves these additional symptoms of hay fever:

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

Section 50565-1 (50565-1)

Keep out of reach of children.

Purpose

Active ingredients (in each caplet)	Purpose
Acetaminophen 500 mg	Pain reliever
Chlorpheniramine Maleate 4 mg	Antihistamine
Phenylephrine HCl 10 mg	Nasal decongestant

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

Do Not Use (Do not use)

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen,
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
if you have ever had an allergic reaction to this product or any of its ingredients.
to make a child sleepy

Coldtac Ultra

NDC 69729-122-06

NDC 69729-122-37

NDC 69729-122-38

Allergy Alert: (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.

Liver Warning: (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.

Overdose Warning (Overdose warning)

Other Information (Other information)

Store at room temperature between 20-25°C (68-77ºF)
Tamper evident: Do not use if pouch is torn, broken or shows any sing of tampering

Inactive Ingredients (Inactive ingredients)

magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc

Sore Throat Warning: (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

Questions Or Comments? (Questions or comments?)

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

When Using This Product: (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 alcohol drinks
be careful when driving a motor vehicle or operating machinery

Stop Use and Ask A Doctor If: (Stop use and ask a doctor if:)

nervousness, dizziness, or sleeplessness occur
pain, nasal congestion, or cough 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, (If pregnant or breast-feeding,)

ask a health professional before use.

Ask A Doctor Before Use If You Have: (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 Ot Pharmacist If You Are: (Ask a doctor ot pharmacist if you are:)

taking the blood thinning drug warfarin
taking sedatives or tranquilizers

Advanced Ingredient Data

[{"name": "SODIUM BENZOATE", "unii": "OJ245FE5EU", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM STARCH GLYCOLATE TYPE A POTATO", "unii": "5856J3G2A2", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "TALC", "unii": "7SEV7J4R1U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SILICON DIOXIDE", "unii": "ETJ7Z6XBU4", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "MAGNESIUM STEARATE", "unii": "70097M6I30", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "STARCH, CORN", "unii": "O8232NY3SJ", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POVIDONE K30", "unii": "U725QWY32X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "ACETAMINOPHEN", "unii": "362O9ITL9D", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "CHLORPHENIRAMINE", "unii": "3U6IO1965U", "classCode": "ACTIB", "strengthNumerator": "4", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "10", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}]

Raw Label Data

All Sections (JSON)

{"Uses": "Temporarily relieves these symptoms of hay fever or other respiratory allergies: headache nasal congestion sinus congestion & pressure runny nose and sneezing minor aches & pain Temporarily relieves these additional symptoms of hay fever: itching of the nose or throat itchy, watery eyes helps clear nasal passages helps decongest sinus opening and passages", "50565-1": "Keep out of reach of children.", "Purpose": "Active ingredients (in each caplet) Purpose Acetaminophen 500 mg Pain reliever Chlorpheniramine Maleate 4 mg Antihistamine Phenylephrine HCl 10 mg Nasal decongestant", "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", "Do not use": "with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, 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 if you have ever had an allergic reaction to this product or any of its ingredients. to make a child sleepy", "Coldtac Ultra": "NDC 69729-122-06 NDC 69729-122-37 NDC 69729-122-38", "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.", "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.", "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.", "Other information": "Store at room temperature between 20-25°C (68-77ºF) Tamper evident: Do not use if pouch is torn, broken or shows any sing of tampering", "Inactive ingredients": "magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc", "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", "Questions or comments?": "Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us", "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 alcohol drinks be careful when driving a motor vehicle or operating machinery", "Stop use and ask a doctor if:": "nervousness, dizziness, or sleeplessness occur pain, nasal congestion, or cough 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.", "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 ot pharmacist if you are:": "taking the blood thinning drug warfarin taking sedatives or tranquilizers"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:36.763647 · Updated: 2026-03-14T23:05:28.061539