(DA) Tabcin Blue Effervescent (V)

Tabcin by

Drug Labeling and Warnings

Tabcin by is a Otc medication manufactured, distributed, or labeled by Pharmadel LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TABCIN FLU- acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, effervescent 
Pharmadel LLC

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(DA) Tabcin Blue Effervescent (V)

Drug Facts

Active ingredients & Purposes

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

  Pain reliever/ fever reducer

• Dextromethorphan HBr 10 mg ...........: Cough suppressant
• Phenylephrine HCl 5 mg .....................: Nasal decongestant

Uses

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

• cough due to minor bronchial irritation
• nasal congestion
• minor aches and pains
• headache
• and temporarily reduces fever

Warnings

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.

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 your doctor or pharmacist before taking this product

Ask a doctor before use if you have

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

Ask a doctor or pharmacist before use if you are

• taking the blood thinning drug warfarin

When using this product

• do not exceed the recommended dosage

Stop use and ask a doctor if

• nervousness, dizziness, or sleeplessness occurs
• pain, cough, 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
• cough comes back or occurs with a rash or headache that lasts. These could be signs of a serious condition.

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

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

■ 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

• each tablet contains: potassium 10mg, sodium 274mg
• store below 77° F(25° C) and in a dry place

Inactive Ingredients

acesulfame potassium, anhydrous citric acid, lemon flavor, polysorbate 80, povidone k-30, simethicone, sodium benzoate, sodium bicarbonate, sucralose, water

Questions or comments?

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

Dist. by:

Pharmadel LLC.

New Castle, DE 19720

Principle Display Panel

TABCIN  FLU
acetaminophen, dextromethorphan hbr, phenylephrine hcl tablet, effervescent

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 55758-445
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	5 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POVIDONE K30 (UNII: U725QWY32X)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SUCRALOSE (UNII: 96K6UQ3ZD4)
SODIUM BICARBONATE (UNII: 8MDF5V39QO)
DIMETHICONE (UNII: 92RU3N3Y1O)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white	Score	no score
Shape	ROUND	Size	24mm
Flavor	LEMON	Imprint Code	V1
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 55758-445-36	36 in 1 CARTON	06/30/2024	06/30/2024
1		2 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M013	06/30/2024	06/30/2024

Labeler - Pharmadel LLC (030129680)

Revised: 10/2024

Document Id: 25a0ebcb-11ba-419c-e063-6394a90a2784

34390-5

Set id: 201f6915-844e-7dcc-e063-6394a90a8aa7

Version: 3

Effective Time: 20241029