Coldtac Ultra
- Manufacturer
- OPMX LLC
- Effective date
- 2026-10-05
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- daily-update
- Hydrated at
- 2026-10-13 04:04:26
Label at a glance#
ProductCOLDTAC ULTRA
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE
Label structure14 sections
Contacts and useful links#
Websitewww.opmx.us
www.opmx.us
www.opmx.usLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
ACTIVE INGREDIENTS (in each tablet)
Acetaminophen 500 mg
Chlorpheniramine Maleate 4 mg
Phenylephrine HCl 10 mg
OTC - PURPOSE SECTION
PURPOSE
Pain Reliever/Fever Reducer
Antihistamine
Nasal decongestant
INDICATIONS & USAGE SECTION
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:
- itching of the nose or throat itchy, watery eyes
- helps clear nasal passages
- helps decongest sinus opening and passages
WARNINGS SECTION
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
OTC - DO NOT USE SECTION
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
OTC - ASK DOCTOR SECTION
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
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are:
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
OTC - WHEN USING SECTION
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
OTC - STOP USE SECTION
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
If pregnant or breast-feeding:ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
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 SECTION
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 |
OTHER SAFETY INFORMATION
Other information:
- Store at room temperature between 25°C (77°F); excursions permitted between 15°C-30°C (59°F-86°F)
- Avoid excessive heat and humidity
- Tamper Evident: do not use if package or blister unit is open or shows any sign of tampering
INACTIVE INGREDIENT SECTION
Inactive ingredients: Microcrystalline cellulose, Polyvinylpyrrolidone, Crospovidone, Magnesium stearate, Colloidal silicon dioxide, Purified talc.
Inactive ingredients: magnesium stearate, povidone, silicon dioxide, sodium benzoate, sodium starch glycolate, starch, talc.
OTC - QUESTIONS SECTION
Questions or comments?
Call: (619) 600-5632 (Mon-Fri 9am-5pm EST) or www.opmx.us
SPL UNCLASSIFIED SECTION
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 69729-133-37
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
PRINCIPAL DISPLAY PANEL - 100 TABLETS
NDC 69729-133-50
COLDTAC ULTRA
Actaminophen 500 mg / Pain reliever
Chlorpheniramine Maleate 4 mg / Antihistamine
Phenylephrine HCl 10 mg / Nasal decongestant
Cold & Flu
Relief Medicine
Alivia los Sintomas de
GRIPE y RESFRIADO
100 Tablets / Tabletas
50 Packs / Sobres
2 Tablets / Tabletas
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0810053181256 | GTIN-13: 0810053181256 EAN-13: 0810053181256 GTIN-12: 810053181256 UPC-A: 810053181256 GTIN storage (14 digits): 00810053181256 | Coldtac Ultra w6 Tablets (3-2 pouches).jpg |
| Barcode | EAN-13 | 0856828008151 | GTIN-13: 0856828008151 EAN-13: 0856828008151 GTIN-12: 856828008151 UPC-A: 856828008151 GTIN storage (14 digits): 00856828008151 | Coldtac Ultra2Vovan.jpg |
| Barcode | EAN-13 | 0856828008410 | GTIN-13: 0856828008410 EAN-13: 0856828008410 GTIN-12: 856828008410 UPC-A: 856828008410 GTIN storage (14 digits): 00856828008410 | Coldtac Ultra 12 Tablets (6-2 pouches)37.jpg |
| Barcode | EAN-13 | 0856828008427 | GTIN-13: 0856828008427 EAN-13: 0856828008427 GTIN-12: 856828008427 UPC-A: 856828008427 GTIN storage (14 digits): 00856828008427 | Coldtac Ultra144Vovan.jpg |
| QR code link | QR Code |  opmx.us/ | Coldtac Ultra w6 Tablets (3-2 pouches).jpg, Coldtac Ultra144Vovan.jpg, Coldtac Ultra 12 Tablets (6-2 pouches)37.jpg, COLDTAC ULTRA 100 BOX.jpg |
DailyMed Product Concepts#
Products#
Every source-derived product name is available through these pages.
- COLDTAC ULTRA
- Acetaminophen, Chlorpheniramine Maleate, Phenylephrine HCl
- PHENYLEPHRINE HYDROCHLORIDE
- PHENYLEPHRINE
- ACETAMINOPHEN
- CHLORPHENIRAMINE MALEATE
- CHLORPHENIRAMINE
- MAGNESIUM STEARATE
- POVIDONE, UNSPECIFIED
- STARCH, CORN
- SODIUM BENZOATE
- SODIUM STARCH GLYCOLATE TYPE A
- TALC
- SILICON DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 69729-133 | 69729-133-38, 69729-133-37, 69729-133-06, 69729-133-27, 69729-133-50 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| PHENYLEPHRINE HYDROCHLORIDE | 04JA59TNSJ | ACTIB |
| ACETAMINOPHEN | 362O9ITL9D | ACTIB |
| CHLORPHENIRAMINE MALEATE | V1Q0O9OJ9Z | ACTIB |
| MAGNESIUM STEARATE | 70097M6I30 | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| STARCH, CORN | O8232NY3SJ | IACT |
| SODIUM BENZOATE | OJ245FE5EU | IACT |
| SODIUM STARCH GLYCOLATE TYPE A | H8AV0SQX4D | IACT |
| TALC | 7SEV7J4R1U | IACT |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2026-07-24 | daily-update | 2026-07-28 05:10:08 |
| 2 | 2024-01-26 | full-release | 2026-06-01 00:07:57 |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 575f6505-ff6d-5079-e063-6394a90accc2 | 0e9d506d-8c0c-ab6b-e063-6294a90a5ab6 | 2026-07-24 | Warnings | 0e9d506d-8c0c-ab6b-e063-6294a90a5ab6 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.