Coldtac Ultra
0e9d506d-8c0c-ab6b-e063-6294a90a5ab6
34390-5
HUMAN OTC DRUG LABEL
Drug Facts
Composition & Product
Identifiers & Packaging
Description
ACTIVE INGREDIENTS (in each tablet) Acetaminophen 500 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg
Medication Information
Warnings and Precautions
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
Indications and 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
Dosage and 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 |
Description
ACTIVE INGREDIENTS (in each tablet) Acetaminophen 500 mg Chlorpheniramine Maleate 4 mg Phenylephrine HCl 10 mg
Section 42229-5
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
Section 44425-7
Other information:
- Store at room temperature between 20-25°C (68-77ºF)
- Avoid excessive heat and humidity
Section 50565-1
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.
Section 50566-9
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.
Section 50567-7
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
Section 50568-5
Ask a doctor or pharmacist before use if you are:
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Section 50569-3
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
Section 50570-1
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
Section 51727-6
Inactive ingredients:magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc
Section 53413-1
Questions or comments?
Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us
Section 53414-9
If pregnant or breast-feeding:ask a health professional before use.
Section 55105-1
PURPOSE
Pain Reliever/Fever Reducer
Antihistamine
Nasal decongestant
Section 55106-9
ACTIVE INGREDIENTS (in each tablet)
Acetaminophen 500 mg
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg
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
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 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 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)
Structured Label Content
Indications and Usage (34067-9)
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
Dosage and Administration (34068-7)
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 |
Warnings and Precautions (34071-1)
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
Section 42229-5 (42229-5)
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
Section 44425-7 (44425-7)
Other information:
- Store at room temperature between 20-25°C (68-77ºF)
- Avoid excessive heat and humidity
Section 50565-1 (50565-1)
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.
Section 50566-9 (50566-9)
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.
Section 50567-7 (50567-7)
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
Section 50568-5 (50568-5)
Ask a doctor or pharmacist before use if you are:
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
Section 50569-3 (50569-3)
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
Section 50570-1 (50570-1)
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
Section 51727-6 (51727-6)
Inactive ingredients:magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc
Section 53413-1 (53413-1)
Questions or comments?
Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or https://www.opmx.us
Section 53414-9 (53414-9)
If pregnant or breast-feeding:ask a health professional before use.
Section 55105-1 (55105-1)
PURPOSE
Pain Reliever/Fever Reducer
Antihistamine
Nasal decongestant
Section 55106-9 (55106-9)
ACTIVE INGREDIENTS (in each tablet)
Acetaminophen 500 mg
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg
Principal Display Panel 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
Principal Display Panel 6 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 12 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 144 Tablets (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)
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Raw Label Data
All Sections (JSON)
Additional Information
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Source: dailymed · Ingested: 2026-02-15T12:02:44.587389 · Updated: 2026-03-14T23:02:26.872598