Tabcin

Manufacturer
Pharmadel LLC
Effective date
2024-10-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 20:53:12

Label at a glance#

ProductTabcin Cough and Cold
Active ingredientDEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE
Label structure9 sections

Indications and uses

For the temporary relief of symptoms due to the common cold/ flu: runny nose sneezing nasal congestion cough due to minor throat and bronchial irritation minor aches and pain headache sore throat and temporarily reduces fever

Dosage and administration

■ adults and children 12 years of age and older: take two (2) tablets fully dissolved in a 4 oz glass of water every 4 hours. Do not exceed 12 tablets in 24 hours, or as directed by a doctor. ■ children under 12 years of age: do not use

Label contents#

Full prescribing information#

Active ingredients & Purposes

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients (in each tablet) Purposes
Acetaminophen 325 mg...................

Pain reliever/ fever reducer

Chlorpheniramine maleate 2 mg .......Antihistamine
Dextromethorphan HBr 10 mg ...........Cough suppressant
Phenylephrine HCl 5 mg .....................Nasal decongestant

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of symptoms due to the common cold/ flu:

  • runny nose
  • sneezing
  • nasal congestion
  • cough due to minor throat and bronchial irritation
  • minor aches and pain
  • headache
  • sore throat
  • and temporarily reduces fever

Warnings

WARNINGS SECTION

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

  • more than 12 tablets in 24 hours, which is the maximum daily amount for this product
  • with other drugs containing 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, and is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.

Do not use

OTC - DO NOT USE SECTION

  • 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 your doctor or pharmacist before taking this product

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • liver disease
  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • glaucoma
  • a breathing problem such as emphysema or chronic bronchitis
  • difficulty in urination due to enlargement of the prostate gland
  • a persistent or chronic cough such as occurs with smoking, asthma, or emphysema
  • a cough is accompanied by excessive phlegm (mucus)

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended dosage
  • may cause marked drowsiness
  • may cause excitability, especially in children
  • may cause drowsiness; alcohol, sedatives, and tranquilizers may increase the drowsiness effect
  • avoid alcoholic beverages while taking this product
  • use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • nervousness, dizziness, or sleeplessness occurs
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur
  • cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of an accidental 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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ adults and children 12 years of age and older: take two (2) tablets fully dissolved in a 4 oz glass of water every 4 hours. Do not exceed 12 tablets in 24 hours, or as directed by a doctor.

■ children under 12 years of age: do not use

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: potassium 10mg, sodium 290mg
  • store below 77° F (25° C) and in a dry place

Inactive ingredients

INACTIVE INGREDIENT SECTION

acesulfame potassium, anhydrous citric acid, FD&C blue #1, FD&C red #40, grape flavor, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, sucralose, water

Questions or comments?

OTC - QUESTIONS SECTION

+1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Dist. by:

SPL UNCLASSIFIED SECTION

Pharmadel LLC.

New Castle, DE 19720

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDP TABCIN PURPLEPDP TABCIN PURPLE

Products#

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-44655758-446-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Source Document#

Source XML

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
25a0f3d4-81f3-a013-e063-6394a90a8a77201f1a11-876d-bc6f-e063-6394a90aa9182024-10-29WarningsExact identifier
spl set id: 201f1a11-876d-bc6f-e063-6394a90aa918

Reported adverse events (FAERS/openFDA)#

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