CORICIDIN HBP MAXIMUM STRENGTH NIGHTTIME COLD AND FLU- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Coricidin HBP Maximum Strength Nighttime Cold and Flu by

Drug Labeling and Warnings

Coricidin HBP Maximum Strength Nighttime Cold and Flu 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

Drug Facts

ACTIVE INGREDIENT

• Active ingredients (in each 30 mL): Purposes
• Acetaminophen 650 mg: Pain reliever/fever reducer
• Dextromethorphan hydrobromide 20 mg: Cough suppressant
• Doxylamine succinate 12.5 mg: Antihistamine

PURPOSE

INDICATIONS & USAGE

Uses

• temporarily relieves these symptoms due to a cold or flu:
  • minor aches and pains
  • headache
  • cough
  • sore throat
  • runny nose
  • sneezing
• temporarily reduces fever

WARNINGS

Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take
more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

Allergy alert: Acetaminophen may cause severe skin or severe allergic reactions. Symptoms may include:

• skin reddening
• blisters
• rash
• hives
• facial swelling
• asthma (wheezing)
• shock

If a skin or general allergic reaction occurs, stop use and seek medical help right away.

Sore throat warning: If sore throat is severe, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea, or vomiting, consult a doctor promptly.
Do not use to sedate children

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 a doctor or pharmacist before taking this product.
• if you have ever had an allergic reaction to this product or any of its ingredients
• in children under 12 years of age

Ask a doctor before use if you have

• liver disease
• glaucoma
• persistent or chronic cough such as occurs with smoking, asthma or emphysema
• difficulty in urination due to enlargement of the prostate gland
• a breathing problem such as emphysema or chronic bronchitis
• cough that occurs with excessive phlegm (mucus)
• a sodium-restricted diet

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 drinks
• be careful when driving a motor vehicle or operating machinery
• alcohol, sedatives, and tranquilizers may increase drowsiness

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 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. 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 for children even if you do not notice any signs or symptoms.

DOSAGE & ADMINISTRATION

Directions

• do not take more than recommended dose
• adults and children 12 years and over: take 30 mL in the dosing cup provided every 4 hours. Do not exceed 150 mL (5 doses) in 24 hours or asdirected by a doctor.
• children under 12 years of age: do not use

OTHER SAFETY INFORMATION

Other information
each 30 mL contains: sodium 38 mg
store between 20º to 25ºC (68º to 77ºF)

INACTIVE INGREDIENT

Inactive ingredients anhydrous citric acid, FD&C blue #1, FD&C red # 40, flavor, glycerin, maltitol solution, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

QUESTIONS

Questions or comments? 1-800-317-2165 (Mon – Fri 9AM – 5PM EST)

PRINCIPAL DISPLAY PANEL

New!

Coricidin®

HBP

COLD RELIEF FOR PEOPLE WITH

HIGH BLOOD PRESSURE†

MAXIMUM STRENGTH

NIGHTTIME

COLD

& FLU

Relieves

Body Aches & Pains

Headache, Fever,

Cough, Sore Throat,

Runny Nose, Sneezing

SUGAR FREE

Alcohol Free

†Decongestant Free

Acetaminophen -

Pain Reliever/Fever Reducer

Dextromethorphan HBr-

Cough Suppressant

Doxylamine succinate-Antihistamine

12 FL OZ (355 mL)

INGREDIENTS AND APPEARANCE

CORICIDIN HBP MAXIMUM STRENGTH NIGHTTIME COLD AND FLU 
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11523-0077
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)	ACETAMINOPHEN	650 mg  in 30 mL
DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS)	DEXTROMETHORPHAN HYDROBROMIDE	20 mg  in 30 mL
DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL)	DOXYLAMINE SUCCINATE	12.5 mg  in 30 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C RED NO. 40 (UNII: WZB9127XOA)
WATER (UNII: 059QF0KO0R)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
SODIUM CITRATE (UNII: 1Q73Q2JULR)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
GLYCERIN (UNII: PDC6A3C0OX)
MALTITOL (UNII: D65DG142WK)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11523-0077-1	355 mL in 1 BOTTLE; Type 0: Not a Combination Product	07/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M012	07/25/2021

Labeler - Bayer HealthCare LLC. (112117283)