CORICIDIN HBP DAY AND NIGHT- dextromethorphan hydrobromide, guaifenesin, acetaminophen, chlorpheniramine maleate kit

Coricidin HBP by

Drug Labeling and Warnings

Coricidin HBP by is a Otc medication manufactured, distributed, or labeled by Bayer HealthCare LLC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Coricidin HBP Day

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each softgel)	Purpose
Dextromethorphan hydrobromide 10 mg	Cough Suppressant
Guaifenesin 200 mg	Expectorant

Uses

• temporarily relieves cough due to minor throat and bronchial irritation as may occur with a cold
• helps loosen phlegm (mucus) and thin bronchial secretions to make coughs more productive

Warnings

Do not use 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 a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• cough that occurs with excessive phlegm (mucus)
• persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Stop use and ask a doctor if cough lasts more than 7 days, reoccurs, or occurs with fever, rash or persistent headache. These could be signs of a serious condition.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away. Abuse of this product can lead to serious injury.

Directions

• do not exceed recommended dose
• do not take the Day and Night products at the same time; wait 4 hours after the last Night dose before starting Day product
• adults and children 12 years and over: 1 or 2 softgels every 4 hours, not more than 6 softgels in 12 hours
• children under 12 years of age: ask a doctor

Other Information

• store between 20° to 25°C (68° to 77°F)
• protect from freezing
• protect from excessive moisture

Inactive Ingredients

FD&C blue no. 1, FD&C red no. 40, gelatin, glycerin, pharmaceutical ink, polyethylene glycol 400, povidone, propylene glycol, sorbitol

SPL UNCLASSIFIED SECTION

Coricidin HBP Night

Drug Facts

ACTIVE INGREDIENT

Active ingredients (in each tablet)	Purpose
Acetaminophen 500 mg	Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg	Antihistamine
Dextromethorphan hydrobromide 15 mg	Cough Suppressant

Uses

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

Warnings

Liver Warning

This product contains acetaminophen.

Sever liver damage may occur if you take

• more than 4 tablets in 12 hours
• with other drugs containing acetaminophen
• 3 or more alcoholic drinks every day 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.
• 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 a MAOI, ask a doctor or pharmacist before taking this product.

Ask a doctor before use if you have

• liver disease
• glaucoma
• trouble urinating due to an enlarged prostate gland
• cough that occurs with excessive phlegm (mucus)
• a breathing problem or persistent or chronic cough as occurs with smoking, asthma, chronic bronchitis, or emphysema

Ask a doctor or pharmacist before use if you are

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

When using this product

• excitability may occur, especially in children
• marked 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 or cough 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 breast-feeding, ask a health professional before use.

Keep out of reach of children. Abuse of this product can lead to serious injury.

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)
• do not take the Day and Night products at the same time; wait 4 hours after the last Day dose before starting Night product
• adults and children 12 years and over: 2 tablets at bedtime and every 6 hours if needed, while symptoms persist, not more than 4 tablets in a 12 hour period
• children under 12 years of age: ask a doctor

Other Information

• store between 20° to 25°C (68° to 77°F)
• protect from excessive moisture
• this product meets the requirements of USP Dissolution Test 2

Inactive Ingredients

carnauba wax, FD&C red No. 40 aluminum lake, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide

Questions or comments?

Call 1-800-317-2165 (MoN-Fri 9AM-5PM EST)

PRINCIPAL DISPLAY PANEL - Kit Carton

DUAL FORMULA PACK

Coricidin ®

HBP

Decongestant-free COLD RELIEF for people

with HIGH BLOOD PRESSURE

DAY

MULTI-SYMPTOM COLD

Guaifenesin - Expectorant

Dextromethorphan HBr - Cough Suppressant

Day Relieves:

• Chest Congestion
• Cough

16 DAY SOFTGELS

NIGHT

Chlorpheniramine Maleate - Antihistamine,

Dextromethorphan HBr - Cough Suppressant,

Acetaminophen - Pain Reliever/Fever Reducer

See New Warnings Information

Night Relieves:

• Runny Nose & Sneezing
• Cough Body Aches
• Fever

8 NIGHT TABLETS

INGREDIENTS AND APPEARANCE

CORICIDIN HBP  DAY AND NIGHT
dextromethorphan hydrobromide, guaifenesin, acetaminophen, chlorpheniramine maleate kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-4765

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-4765-1	1 in 1 CARTON; Type 0: Not a Combination Product	08/28/2009

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	2 BLISTER PACK	16
Part 2	2 BLISTER PACK	8

Part 1 of 2

CORICIDIN HBP  DAY
dextromethorphan hydrobromide and guaifenesin capsule, gelatin coated

Product Information
Item Code (Source)	NDC: 11523-4221
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	10 mg
GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ)	GUAIFENESIN	200 mg

Inactive Ingredients
Ingredient Name	Strength
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GELATIN (UNII: 2G86QN327L)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE (UNII: FZ989GH94E)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITOL (UNII: 506T60A25R)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	20mm
Flavor		Imprint Code	C;DAY
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-4221-1	2 in 1 CARTON
1		8 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	08/28/2009

Part 2 of 2

CORICIDIN HBP  NIGHT
acetaminophen, chlorpheniramine maleate and dextromethorphan hydrobromide tablet

Product Information
Item Code (Source)	NDC: 11523-4111
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	500 mg
CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U)	CHLORPHENIRAMINE MALEATE	2 mg
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	15 mg

Inactive Ingredients
Ingredient Name	Strength
CARNAUBA WAX (UNII: R12CBM0EIZ)
FD&C RED NO. 40 (UNII: WZB9127XOA)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYPROMELLOSES (UNII: 3NXW29V3WO)
LACTOSE (UNII: J2B2A4N98G)
MAGNESIUM STEARATE (UNII: 70097M6I30)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
POVIDONE (UNII: FZ989GH94E)
STEARIC ACID (UNII: 4ELV7Z65AP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	red	Score	no score
Shape	OVAL	Size	18mm
Flavor		Imprint Code	C;NIGHT
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-4111-1	2 in 1 CARTON
1		4 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	08/28/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part341	08/28/2009

Labeler - Bayer HealthCare LLC. (112117283)