Coldtac Severe

Manufacturer
OPMX LLC
Effective date
2026-09-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
daily-update
Hydrated at
2026-09-30 01:01:17

Label at a glance#

ProductAcetaminophen, Guaifenesin, Dextromethorphan HBr, Phenylephrine HCl
Active ingredientACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Acetaminophen 325mg

Dextromethorphan HBr 10mg

Guaifenesin 200mg

Phenylephrine HCl 5mg

OTC - PURPOSE SECTION

Pain reliever/fever reducer

Cough suppressant

Expectorant

Nasal decongestant

INACTIVE INGREDIENT SECTION

FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide

DOSAGE & ADMINISTRATION SECTION

  • Take only as directed (See overdose warning)
  • Do not exceed 4 doses per 24-hours
  • Adults and children 12 years and over: take 2 softgels with water every 4 hours
  • Children 4 to under 12 years: ask a doctor
  • When using other Nighttime or Daytime products, carefully read each label to ensure correct dosing

INDICATIONS & USAGE SECTION

Temporarily relieves common cold/flu symptoms:

  • Nasal congestion
  • Sinus congestion & pressure
  • Cough due to minor throat & bronchial irritation
  • Minor aches & pain
  • Headache
  • Fever
  • Sore throat
  • Reduces swelling of nasal passages
  • Temporarily restore freer breathing through the nose
  • Promotes nasal and/or sinus drainage
  • Helps loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive.

WARNINGS SECTION

Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take more than 4 doses 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.

Ask a doctor before use if you have:

Liver disease
High blood pressure
Thyroid disease
Diabetes
Trouble urinating due to enlarged prostate gland
Cough that occurs with too much phlegm (mucus)
Persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.

When using this product, do not use more than directed.

Stop use and ask a doctor if:

You get nervous, dizzy, or sleepless
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
Cough comes back or occurs with rash or headache that lasts

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OVERDOSAGE SECTION

OVERDOSE WARNING: Read directions carefully. 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 SAFETY INFORMATION

store at room temperature between 20-25°C (68-77ºF)

avoid excessive heat and humidity

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COLDTACCOLDTAC

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
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05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
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42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-782-102024-05-19C16284748780-1d6a99b39-96b2-a426-e053-dadaa90af4c2Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel)
69729-782-102024-05-19C16284748780-1d6a99b39-96b2-a426-e053-dadaa90af4c2Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel)
69729-782-102024-01-30C16284748780-1d6a99b39-96b2-a426-e053-dadaa90af4c2Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel)
69729-782-102024-01-30C16284748780-1d6a99b39-96b2-a426-e053-dadaa90af4c2Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel)
69729-782-102022-04-12C16284748780-1d6a99b39-96b2-a426-e053-dadaa90af4c2Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel)
69729-782-102022-04-12C16284748780-1d6a99b39-96b2-a426-e053-dadaa90af4c2Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel)
69729-782-102022-01-28C16284748780-1d6a99b39-96b2-a426-e053-dadaa90af4c2Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel)
69729-782-102022-01-28C16284748780-1d6a99b39-96b2-a426-e053-dadaa90af4c2Coldtac Severe (Acetaminophen 325mg, Dextromethorphan HBr 10mg, Guaifenesin 200mg, Phenylephrine HCl 5mg Softgel)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-78269729-782-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-05-17full-release2026-06-01 00:12:45

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
18adbc15-b127-cc7e-e063-6394a90a1e9c9a164cfc-b623-9a9f-e053-2a95a90a01732024-05-17WarningsExact identifier
spl set id: 9a164cfc-b623-9a9f-e053-2a95a90a0173

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.