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

United States - English - NLM (National Library of Medicine)

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Active ingredient:
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)
Available from:
Proficient Rx LP
Administration route:
ORAL
Prescription type:
OTC DRUG
Authorization status:
OTC monograph final
Authorization number:
71205-312-10

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

coated

Proficient Rx LP

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they

comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

----------

Coricidin

HBP Cold & Flu

Drug Facts

Active ingredients

(in each tablet)

Purpos e

Acetaminophen 325 mg

Pain reliever/

fever reducer

Chlorpheniramine

maleate 2 mg

Antihistamine

Us es

Warnings

Liver Warning

This product contains acetaminophen. Sever liver damage may occur if

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

Ask a doctor or pharmacist before use if the user is

®

temporarily relieves

minor aches and pains

headache

sneezing

runny nose

temporarily reduces fever

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.

liver disease

a breathing problem such as emphysema or chronic bronchitis

glaucoma

trouble urinating due to an enlarged prostate gland

When using this product

Stop use and ask a doctor if

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

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

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?

taking the blood thinning drug warfarin

taking sedatives or tranquilizers

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

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

do not use more than directed (see overdose warning)

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

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 :

10 TABLETS

Relabeled by:

Proficient Rx LP

Thousand Oaks, CA 91320

Runny Nose

Sneezing

Body Aches

and Pains

Fever

CORICIDIN HBP COLD AND FLU

acetaminophen and chlorpheniramine maleate tablet, film coated

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:7120 5-312(NDC:11523-4325)

Route of Administration

ORAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

ACETAMINO PHEN (UNII: 36 2O9 ITL9 D) (ACETAMINOPHEN - UNII:36 2O9 ITL9 D)

ACETAMINOPHEN

325 mg

CHLO RPHENIRAMINE MALEATE (UNII: V1Q0 O9 OJ9 Z) (CHLORPHENIRAMINE -

UNII:3U6 IO 19 6 5U)

CHLORPHENIRAMINE

MALEATE

2 mg

Inactive Ingredients

Ingredient Name

Stre ng th

STARCH, CO RN (UNII: O8 232NY3SJ)

FD&C RED NO . 4 0 (UNII: WZB9 127XOA)

ALUMINUM O XIDE (UNII: LMI26 O6 9 33)

ANHYDRO US LACTO SE (UNII: 3SY5LH9 PMK)

MAGNESIUM STEARATE (UNII: 70 0 9 7M6 I30 )

MICRO CRYSTALLINE CELLULO SE (UNII: OP1R32D6 1U)

PO LYETHYLENE GLYCO L, UNSPECIFIED (UNII: 3WJQ0 SDW1A)

PO LYVINYL ALCO HO L, UNSPECIFIED (UNII: 532B59 J9 9 0 )

PO VIDO NE, UNSPECIFIED (UNII: FZ9 8 9 GH9 4E)

TALC (UNII: 7SEV7J4R1U)

TITANIUM DIO XIDE (UNII: 15FIX9 V2JP)

Proficient Rx LP

Product Characteristics

Color

re d

S core

no sco re

S hap e

ROUND

S iz e

11mm

Flavor

Imprint Code

Contains

Packag ing

#

Item Code

Package Description

Marketing Start Date

Marketing End Date

1

NDC:7120 5-312-10

1 in 1 CARTON

0 9 /0 1/20 19

1

10 in 1 BLISTER PACK; Type 0 : No t a Co mbinatio n Pro duct

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

OTC mo no graph final

pa rt341

10 /0 1/20 13

Labeler -

Proficient Rx LP (079196022)

Establishment

Name

Ad d re s s

ID/FEI

Busine ss Ope rations

Pro ficient Rx LP

0 79 19 6 0 22

RELABEL(7120 5-312)

Revised: 10/2019

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