coricidin hbp maximum strength cold & flu day & night liquidgels

coricidin hbp maximum strength cold & flu day & night liquidgels
SPL v5
SPL
SPL Set ID e4f3f906-2252-21d1-e053-2a95a90a85df
Route
oral
Published
Effective Date 2020-07-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
acetaminophen (325 mg) guaifenesin (200 mg) doxylamine (6.25 mg) dextromethorphan (10 mg)
Inactive Ingredients
mica lecithin, soybean shellac sorbitol titanium dioxide water sodium hydroxide sorbitan ferrosoferric oxide potassium aluminum disilicate povidone fd&c yellow no. 6 medium-chain triglycerides propylene glycol polyethylene glycol, unspecified gelatin glycerin soybean oil fd&c blue no. 1 d&c yellow no. 10

Identifiers & Packaging

Pill Appearance
Imprint: CHBPN Shape: oval Color: orange Color: green Size: 18 mm Size: 17 mm Score: 1
Marketing Status
otc monograph drug active Since 2020-07-01

Description

Coricidin HBP® Maximum Strength Cold & Flu Day Liquid Gels


Medication Information

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.

Active Ingredient

Active ingredients (in each capsule)Purposes

Acetaminophen 325 mg…………….………...Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

Doxylamine succinate 6.25 mg……………………………...Antihistamine

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
Uses

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache

· sore throat

· helps loosen phlegm (mucus) and thin bronchial secretions to make

coughs more productive

· temporarily reduces fever

Dosage and Administration

Directions

· do not take more than the recommended dose

· do not take the Day and Night products at the same time; wait 4

hours after taking the last Day dose before taking the Night product.

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 4 capsules in 12 hours or as

directed by a doctor.

· children under 12 years of age: do not use

Directions

Directions

· do not take more than the recommended dose

· do not take the Day and Night products at the same time; wait 4

hours after taking the last Night dose before taking the Day product.

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 6 capsules in 12 hours or as

directed by a doctor.

· children under 12 years of age: do not use

Other Information

Other information

· store at 15º-25ºC (59º-77ºF)

Description

Coricidin HBP® Maximum Strength Cold & Flu Day Liquid Gels

Section 42229-5

Coricidin HBP® Maximum Strength Cold & Flu Day Liquid Gels

Section 50565-1

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.

Section 50566-9

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

Section 50567-7

When using this product

● may cause marked drowsiness

● avoid alcoholic beverages

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

● excitability may occur, especially in children

Section 50568-5

Ask a doctor before use if you have

● liver disease ● glaucoma

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

● cough that occurs with excessive phlegm (mucus)

● a breathing problem such as emphysema or chronic bronchitis

● difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

Section 50570-1

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

Section 51727-6

Inactive ingredients D&C yellow No.10, FD&C blue No.1, gelatin, glycerin, lecithin, medium-chain triglycerides, silica, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, soybean oil, titanium dioxide

Section 51945-4

Coricidin® HBP

COLD RELIEF FOR PEOPLE WITH HIGH BLOOD PRESSUREƗ

MAXIMUM STRENGTH

COLD & FLU DAY

ACETAMINOPHEN - Pain Reliever/Fever Reducer

GUAIFENESIN - Expectorant

Relieves

  • Body Aches & Pains
  • Headache
  • Chest Congestion
  • Sore Throat
  • Fever

Ɨ Decongestant Free

16 LIQUID GELS

(Liquid Filled Capsules)

COLD & FLU NIGHT

DOXYLAMINE SUCCINATE - Antihistamine

ACETAMINOPHEN - Pain Reliever/Fever Reducer

DEXTROMETHORPHAN HBr- Cough Suppressant

RELIEVES

  • Body Aches & Pains
  • Headache
  • Runny Nose & Sneezing
  • Cough
  • Sore Throat
  • Fever

Ɨ Decongestant Free

8 LIQUID GELS

(Liquid Filled Capsules)

Section 53413-1

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

Section 53414-9

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

Section 60561-8

Other information

· store at 15º-25ºC (59º-77ºF)

Stop Use

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.

Do Not Use

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 have ever had an allergic reaction to this product or any of its

ingredients

● in children under 12 years of age

Aska A Doctor

Ask a doctor before use if you have

● liver disease

● persistent or chronic cough such as occurs with smoking, asthma,chronic bronchitis,

or emphysema

● cough that occurs with excess phelgm

Liver Warning

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.

Active Ingredients

Active ingredients (in each capsule) Purposes

Acetaminophen 325 mg…………….………..Pain reliever/fever reducer

Guaifenesin 200 mg…………………………………………...Expectorant

Inactive Ingrediens

Inactive ingredients FD&C Yellow#6, gelatin, glycerin, iron oxide black, lecithin, medium-chain triglycerides, mica, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments?

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

Ask A Doctor Or Pharmacist

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


Structured Label Content

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.

Active Ingredient (55106-9)

Active ingredients (in each capsule)Purposes

Acetaminophen 325 mg…………….………...Pain reliever/fever reducer

Dextromethorphan hydrobromide 10 mg……………Cough suppressant

Doxylamine succinate 6.25 mg……………………………...Antihistamine

Uses (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
Uses

Uses

· temporarily relieves these symptoms due to a cold or flu:

· minor aches and pains · headache

· sore throat

· helps loosen phlegm (mucus) and thin bronchial secretions to make

coughs more productive

· temporarily reduces fever

Dosage and Administration (34068-7)

Directions

· do not take more than the recommended dose

· do not take the Day and Night products at the same time; wait 4

hours after taking the last Day dose before taking the Night product.

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 4 capsules in 12 hours or as

directed by a doctor.

· children under 12 years of age: do not use

Directions

Directions

· do not take more than the recommended dose

· do not take the Day and Night products at the same time; wait 4

hours after taking the last Night dose before taking the Day product.

· adults and children 12 years and over: take 2 capsules with water

every 4 hours. Do not exceed 6 capsules in 12 hours or as

directed by a doctor.

· children under 12 years of age: do not use

Other Information (Other information)

Other information

· store at 15º-25ºC (59º-77ºF)

Section 42229-5 (42229-5)

Coricidin HBP® Maximum Strength Cold & Flu Day Liquid Gels

Section 50565-1 (50565-1)

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.

Section 50566-9 (50566-9)

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

Section 50567-7 (50567-7)

When using this product

● may cause marked drowsiness

● avoid alcoholic beverages

● alcohol, sedatives, and tranquilizers may increase drowsiness

● be careful when driving a motor vehicle or operating machinery

● excitability may occur, especially in children

Section 50568-5 (50568-5)

Ask a doctor before use if you have

● liver disease ● glaucoma

● persistent or chronic cough such as occurs with smoking, asthma,

or emphysema

● cough that occurs with excessive phlegm (mucus)

● a breathing problem such as emphysema or chronic bronchitis

● difficulty in urination due to enlargement of the prostate gland

Ask a doctor or pharmacist before use if you are

● taking the blood thinning drug warfarin

● taking sedatives or tranquilizers

Section 50570-1 (50570-1)

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

Section 51727-6 (51727-6)

Inactive ingredients D&C yellow No.10, FD&C blue No.1, gelatin, glycerin, lecithin, medium-chain triglycerides, silica, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, soybean oil, titanium dioxide

Section 51945-4 (51945-4)

Coricidin® HBP

COLD RELIEF FOR PEOPLE WITH HIGH BLOOD PRESSUREƗ

MAXIMUM STRENGTH

COLD & FLU DAY

ACETAMINOPHEN - Pain Reliever/Fever Reducer

GUAIFENESIN - Expectorant

Relieves

  • Body Aches & Pains
  • Headache
  • Chest Congestion
  • Sore Throat
  • Fever

Ɨ Decongestant Free

16 LIQUID GELS

(Liquid Filled Capsules)

COLD & FLU NIGHT

DOXYLAMINE SUCCINATE - Antihistamine

ACETAMINOPHEN - Pain Reliever/Fever Reducer

DEXTROMETHORPHAN HBr- Cough Suppressant

RELIEVES

  • Body Aches & Pains
  • Headache
  • Runny Nose & Sneezing
  • Cough
  • Sore Throat
  • Fever

Ɨ Decongestant Free

8 LIQUID GELS

(Liquid Filled Capsules)

Section 53413-1 (53413-1)

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

Section 53414-9 (53414-9)

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

Section 60561-8 (60561-8)

Other information

· store at 15º-25ºC (59º-77ºF)

Stop Use (Stop use)

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.

Do Not Use (Do not use)

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 have ever had an allergic reaction to this product or any of its

ingredients

● in children under 12 years of age

Aska A Doctor (Aska a doctor)

Ask a doctor before use if you have

● liver disease

● persistent or chronic cough such as occurs with smoking, asthma,chronic bronchitis,

or emphysema

● cough that occurs with excess phelgm

Liver Warning

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.

Active Ingredients (Active ingredients)

Active ingredients (in each capsule) Purposes

Acetaminophen 325 mg…………….………..Pain reliever/fever reducer

Guaifenesin 200 mg…………………………………………...Expectorant

Inactive Ingrediens (Inactive ingrediens)

Inactive ingredients FD&C Yellow#6, gelatin, glycerin, iron oxide black, lecithin, medium-chain triglycerides, mica, polyethylene glycol, potassium aluminum silicate, povidone, propylene glycol, purified water, shellac, sodium hydroxide, sorbitol sorbitan solution, titanium dioxide

Questions Or Comments? (Questions or comments?)

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

Ask A Doctor Or Pharmacist (Ask a doctor or pharmacist)

Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

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. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.


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