Coricidin ®

Coricidin ®
SPL v8
SPL
SPL Set ID de95d2dd-e766-f7ec-e053-2995a90afc5f
Route
ORAL
Published
Effective Date 2022-05-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Acetaminophen (325 mg) Guaifenesin (200 mg)
Inactive Ingredients
Water Sorbitol Mica Lecithin, Soybean Sodium Hydroxide Medium-chain Triglycerides Shellac Fd&c Yellow No. 6 Sorbitan Potassium Aluminum Disilicate Polyethylene Glycol, Unspecified Povidone Titanium Dioxide Ferrosoferric Oxide Propylene Glycol Gelatin Glycerin

Identifiers & Packaging

Pill Appearance
Imprint: CHBPD Shape: oval Color: orange Size: 18 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-05-01

Description

Drug Facts


Medication Information

Description

Drug Facts

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

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
Section 42229-5

Drug Facts

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 50569-3

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 is accompanied by excessive phlegm (mucus)

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

Section 53414-9

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

Section 55105-1
Active ingredients



(in each tablet)
Purpose
Acetaminophen 325 mg Pain reliever/ fever reducer
Guaifenesin 200 mg Expectorant
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

Directions

• do not take more than the recommended dose

• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not

exceed 10 capsules in 24 hours or as directed by a doctor.

• children under 12 years of age: 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

Other Information

● store at 15º-25ºC (59º-77ºF)

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

Principal Display Panel 24 Liquid Gels

Coricidin ®



HIGH BLOOD PRESSURE





Acetaminophen - Pain Reliever/Fever Reducer

Guaifenesin - Expectorant

24 Liquid Gels


Structured Label Content

?

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

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
Section 42229-5 (42229-5)

Drug Facts

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 50569-3 (50569-3)

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 is accompanied by excessive phlegm (mucus)

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

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active ingredients



(in each tablet)
Purpose
Acetaminophen 325 mg Pain reliever/ fever reducer
Guaifenesin 200 mg Expectorant
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

Directions

• do not take more than the recommended dose

• adults and children 12 years and over: take 2 capsules with water every 4 hours. Do not

exceed 10 capsules in 24 hours or as directed by a doctor.

• children under 12 years of age: 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

Other Information (Other information)

● store at 15º-25ºC (59º-77ºF)

Inactive Ingredients (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

Principal Display Panel 24 Liquid Gels (PRINCIPAL DISPLAY PANEL - 24 Liquid Gels)

Coricidin ®



HIGH BLOOD PRESSURE





Acetaminophen - Pain Reliever/Fever Reducer

Guaifenesin - Expectorant

24 Liquid Gels


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)