CORICIDIN HBP COLD AND FLU- acetaminophen and chlorpheniramine maleate tablet, film coated

Coricidin HBP by

Drug Labeling and Warnings

Coricidin HBP by is a Otc medication manufactured, distributed, or labeled by Proficient Rx LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)	Purpose
Acetaminophen 325 mg	Pain reliever/ fever reducer
Chlorpheniramine maleate 2 mg	Antihistamine

Uses

• temporarily relieves
  • minor aches and pains
  • headache
  • sneezing
  • runny nose
• temporarily reduces fever

Warnings

Liver Warning

This product contains acetaminophen. Sever liver damage may occur if

• adult takes more than 12 tablets in 24 hours
• child takes more than 5 tablets in 24 hours
• taken with other drugs containing acetaminophen
• adult has 3 or more alcoholic drinks everyday while using this product.

Do not use with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.

Ask a doctor before use if the user has

• liver disease
• a breathing problem such as emphysema or chronic bronchitis
• glaucoma
• trouble urinating due to an enlarged prostate gland

Ask a doctor or pharmacist before use if the user is

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

When using this product

• excitability may occur, especially in children
• drowsiness may occur
• avoid alcoholic beverages
• alcohol, sedatives and tranquilizers may increase drowsiness
• use caution when driving a motor vehicle or operating machinery

Stop use and ask a doctor if

• pain gets worse or lasts more than 5 days (children 6 to under 12 years) or 10 days (adults)
• fever gets worse or lasts more than 3 days
• redness or swelling is present
• new symptoms occur

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

Overdose Warning

Taking more than the recommended dose may cause liver damage. In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.

Directions

• do not use more than directed (see overdose warning)

• Adults and children 12 years and over:

  2 tablets every 4 to 6 hours, not more than 12 tablets in 24 hours

• Children 6 to under 12 years of age:

  1 tablet every 4 to 6 hours, not more than 5 tablets in 24 hours

• Children under 6 years of age:

  ask a doctor

Other information

• store between 20° to 25°C (68° to 77°F)

Inactive ingredients

corn starch, FD&C red No. 40 aluminum lake, lactose anhydrous, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, talc, titanium dioxide

Questions or comments?

Call 1-800-317-2165

PRINCIPAL DISPLAY PANEL - 10 Tablet Carton

71205-312-10

Coricidin

HBP

Decongestant-free

COLD SYMPTOM RELIEF for people with

HIGH BLOOD PRESSURE

Chlorpheniramine - Antihistamine,

Acetaminophen - Pain Reliever/Fever Reducer

See New Warnings Information

COLD

& FLU

Relieves:

• Runny Nose
• Sneezing
• Body Aches
  and Pains
• Fever

10 TABLETS

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

INGREDIENTS AND APPEARANCE

CORICIDIN HBP  COLD AND FLU
acetaminophen and chlorpheniramine maleate tablet, film coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71205-312(NDC:11523-4325)
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	325 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg

Inactive Ingredients
Ingredient Name	Strength
STARCH, CORN (UNII: O8232NY3SJ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	ROUND	Size	11mm
Flavor		Imprint Code	CF
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71205-312-10	1 in 1 CARTON	09/01/2019
1		10 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	10/01/2013

Labeler - Proficient Rx LP (079196022)

Establishment
Name	Address	ID/FEI	Business Operations
Proficient Rx LP		079196022	RELABEL(71205-312)