Coricidin Hbp Nighttime Multi-symptom Cold Liquid

Coricidin Hbp Nighttime Multi-symptom Cold Liquid
SPL v7
SPL
SPL Set ID 513ca24f-1262-4a2d-e054-00144ff8d46c
Route
ORAL
Published
Effective Date 2015-11-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Doxylamine (6.25 mg) Acetaminophen (325 mg) Dextromethorphan (15 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Blue No. 1 Fd&c Red No. 40 High Fructose Corn Syrup Polyethylene Glycol, Unspecified Propylene Glycol Water Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-11-20

Description

Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 15 mg Cough suppresant Doxylamine succinate 6.25 mg Antihistamine

Purpose

Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 15 mg Cough suppresant Doxylamine succinate 6.25 mg Antihistamine


Medication Information

Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 15 mg Cough suppresant
Doxylamine succinate 6.25 mg Antihistamine

Description

Acetaminophen 325 mg Pain reliever/fever reducer Dextromethorphan hydrobromide 15 mg Cough suppresant Doxylamine succinate 6.25 mg Antihistamine

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
Section 51945-4

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
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.
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.

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

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)

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.

Active Ingredients (in Each 15 Ml)
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 15 mg Cough suppresant
Doxylamine succinate 6.25 mg Antihistamine

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

Structured Label Content

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
Section 51945-4 (51945-4)

Purpose
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 15 mg Cough suppresant
Doxylamine succinate 6.25 mg Antihistamine

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
Do Note Use (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.
Allergy Alert (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.

Liver Warning (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
Other Information (Other information)
  • each 15 mL contains: sodium 18 mg
  • store at 20º-25ºC (68º-77ºF)
Sore Throat Warning (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.

Inactive Ingredients (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)

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

When Using This Product (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 (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)

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

Keep Out of Reach of Children (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.

Active Ingredients (in Each 15 Ml) (Active ingredients (in each 15 mL))
Acetaminophen 325 mg Pain reliever/fever reducer
Dextromethorphan hydrobromide 15 mg Cough suppresant
Doxylamine succinate 6.25 mg Antihistamine

Ask A Doctor Before Use If You Have (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 (Ask a doctor or pharmacist before use if you are)
  • taking the blood thinning drug warfarin
  • taking sedatives or tranquilizers

Advanced Ingredient Data


Raw Label Data

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