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Coricidin HBP Nighttime Multi-Symptom Cold

Dosage form: liquid
Ingredients: DOXYLAMINE SUCCINATE 6.25mg in 15mL, ACETAMINOPHEN 325mg in 15mL, DEXTROMETHORPHAN HYDROBROMIDE 15mg in 15mL
Labeler: Bayer HealthCare LLC.
NDC Code: 11523-4358

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 Nighttime Multi-Symptom Cold Liquid

Drug Facts

Active ingredients (in each 15 mL)
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 15 mgCough suppresant
Doxylamine succinate 6.25 mgAntihistamine

Purpose
Acetaminophen 325 mgPain reliever/fever reducer
Dextromethorphan hydrobromide 15 mgCough suppresant
Doxylamine succinate 6.25 mgAntihistamine

Uses

temporarily relieves common cold/flu symptoms:

  • headache
  • sore throat
  • runny nose
  • minor aches and pains
  • cough due to minor throat and bronchial irritation
  • sneezing
  • fever

Warnings

Liver warning

This product contains acetaminophen. Severe liver damage may occur if you take

  • more than 120 mL (4 doses) in 24 hours, which is the maximum daily amount
  • 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 note use
  • with any other products containing acetaminophen (prescription or nonprescription). If you are no 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.

Ask a doctor before use if you have
  • liver disease
  • cough that lasts or is chronic such as occurs with smoking, asthma or emphysema
  • trouble urinating due to an enlarged prostate gland
  • a breathing problem such as emphysema or chronic bronchitis
  • cough that occurs with too much phlegm (mucus)
  • glaucoma
  • 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
  • fever gets worse or lasts more than 3 days
  • cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
  • pain, cough, or nasal congestion gets worse or lasts more than 7 days
  • new symptoms occur
  • redness or swelling is present

If pregnant or breast-feeding

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

Keep out of reach of children

Keep out of reach of children. In case of overdose, get medical help

or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.

Directions
  • do not take more than directed
  • adults and children 12 years and over: take 30 mL in the dosing cup provided every 6 hours while symptoms last
  • do not exceed 120 mL (4 doses) in 24 hours, unless directed by a doctor
  • children under 12 years: ask a doctor

Other information
  • each 15 mL contains: sodium 18 mg
  • store at 20º-25ºC (68º-77ºF)

Inactive ingredients

alcohol 10%, anhydrous citric acid, FD&C blue no.1, FD&C red no.40, flavor, high fructose corn syrup, polyethylene glycol, propylene glycol, purified water, saccharin sodium, sodium citrate

Questions or comments

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

CORICIDIN HBP NIGHTTIME MULTI-SYMPTOM COLD 
acetaminophen,dextromethorphan hydrobromide, doxylamine succinate liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-4358
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DOXYLAMINE SUCCINATE (DOXYLAMINE) DOXYLAMINE SUCCINATE6.25 mg  in 15 mL
ACETAMINOPHEN (ACETAMINOPHEN) ACETAMINOPHEN325 mg  in 15 mL
DEXTROMETHORPHAN HYDROBROMIDE (DEXTROMETHORPHAN) DEXTROMETHORPHAN HYDROBROMIDE15 mg  in 15 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
FD&C BLUE NO. 1 
FD&C RED NO. 40 
HIGH FRUCTOSE CORN SYRUP 
POLYETHYLENE GLYCOLS 
PROPYLENE GLYCOL 
WATER 
SACCHARIN SODIUM 
Product Characteristics
Color    Score    
ShapeSize
FlavorCHERRYImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:11523-4358-1355 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34111/20/2015
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 06/2017
 
Bayer HealthCare LLC.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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