Tabcin

Manufacturer
Pharmadel LLC
Effective date
2024-06-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 20:59:53

Label at a glance#

ProductTabcin Extra Strength
Active ingredientCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDE, ACETAMINOPHEN
Label structure9 sections

Indications and uses

For the temporary relief of symptoms due to the common cold/ flu: runny nose sneezing nasal congestion minor aches and pain headache 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: ask a doctor

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
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
  • minor aches and pain
  • headache
  • 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

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 prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or 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

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 drowsiness
  • may cause excitability, especially in children
  • 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 or nasal congestion persists for more than 7 days
  • fever gets worse or lasts more than 3 days
  • redness or swelling is present
  • new symptoms occur

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: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: potassium 10mg, sodium 246mg
  • store in a cool dry place
  • protect from sunlight

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions & 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

Principle Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tabcin Red PDPTabcin Red PDP

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-40855758-408-36

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
25b2c5be-8542-bc4a-e063-6394a90ab1071ad172fb-d4b2-e28c-e063-6294a90a751f2024-10-30WarningsExact identifier
spl set id: 1ad172fb-d4b2-e28c-e063-6294a90a751f

Reported adverse events (FAERS/openFDA)#

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