Coricidin HBP Maximum Strength Cold & Flu Day & Night Liquidgels

SPL UNCLASSIFIED SECTION

Coricidin HBP® Maximum Strength Cold & Flu Day Liquid Gels

Active ingredients

Active ingredients (in each capsule) Purposes

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

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

Purpose

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

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

● 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

Ask a doctor or pharmacist

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

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.

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.

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

· store at 15º-25ºC (59º-77ºF)

Inactive ingrediens

Inactive ingredientsFD&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

Coricidin HBP Maximum Stregth Cold & Flu Night Liquid Gels

OTC - ACTIVE INGREDIENT SECTION

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

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.

OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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

OTC - WHEN USING SECTION

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

DOSAGE & ADMINISTRATION SECTION

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

OTHER SAFETY INFORMATION

Other information

· store at 15º-25ºC (59º-77ºF)

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Coricidin® HBP Maximum Strength Cold & Flu Liquid Gels

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Coricidin® HBP

COLD RELIEF FOR PEOPLE WITH HIGH BLOOD PRESSUREƗ

MAXIMUM STRENGTH

COLD & FLU DAY

ACETAMINOPHEN - Pain Reliever/Fever Reducer

GUAIFENESIN - Expectorant

Relieves

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

Ɨ Decongestant Free

8 LIQUID GELS

(Liquid Filled Capsules)

Body Aches & Pains
Headache
Chest Congestion
Sore Throat
Fever

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