Kroger 626t Nighttme Severe Cold And Flu

Drug Facts

Composition & Product

Active Ingredients

Dextromethorphan (10 mg) Acetaminophen (325 mg) Doxylamine (6.25 mg) Phenylephrine (5 mg)

Inactive Ingredients

Polyethylene Glycol, Unspecified Shellac Glycerin Fd&c Blue No. 1 Gelatin Water Sorbitol Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: 72 Shape: bullet Color: green Size: 16 mm Score: 1

Marketing Status

OTC MONOGRAPH DRUG Active Since 2020-05-29

Medication Information

Warnings and Precautions

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take

more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Allergy Alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

Skin reddening

Blisters

Rash

If a skin 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.

Indications and Usage

temporarily relieves common cold/flu symptoms:

nasal congestion

sinus congestion & pressure

cough due to minor throat & bronchial irritation

cough to help you sleep

minor aches & pains

headache

fever

sore throat

runny nose & sneezing

reduces swelling of nasal passages

temporarily restores freer breathing through the nose

promotes nasal and/or sinus drainage

Dosage and Administration

take only as directed

do not exceed 8 Softgels per 24 hours

adults & children 12 yrs & over 2 Softgels with water every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Description

Acetaminophen PhenylephrineHCl, Doxylamine Succinate Dextromethorphan HBr

Section 50565-1

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.

Section 51727-6

FD&C BLUE #1, GELATN, GLYCERIN, POLYETHYLENE GLYCOL, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SHELLAC, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE

Section 51945-4

Section 55105-1

Pain reliever/Fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Section 55106-9

Acetaminophen
PhenylephrineHCl,
Doxylamine Succinate
Dextromethorphan HBr

Structured Label Content

Indications and Usage (34067-9)

temporarily relieves common cold/flu symptoms:

nasal congestion

sinus congestion & pressure

cough due to minor throat & bronchial irritation

cough to help you sleep

minor aches & pains

headache

fever

sore throat

runny nose & sneezing

reduces swelling of nasal passages

temporarily restores freer breathing through the nose

promotes nasal and/or sinus drainage

Dosage and Administration (34068-7)

take only as directed

do not exceed 8 Softgels per 24 hours

adults & children 12 yrs & over 2 Softgels with water every 6 hrs
children 4 to under 12 yrs ask a doctor
children under 4 yrs do not use

Warnings and Precautions (34071-1)

Liver warning

This product contains acetaminophen.

Severe liver damage may occur if you take

more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product

with other drugs containing acetaminophen

3 or more alcoholic drinks every day while using this product

Allergy Alert:

Acetaminophen may cause severe skin reactions. Symptoms may include:

Skin reddening

Blisters

Rash

If a skin 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.

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 (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.

Section 51727-6 (51727-6)

FD&C BLUE #1, GELATN, GLYCERIN, POLYETHYLENE GLYCOL, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SHELLAC, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Pain reliever/Fever reducer
Cough suppressant
Antihistamine
Nasal decongestant

Section 55106-9 (55106-9)

Acetaminophen
PhenylephrineHCl,
Doxylamine Succinate
Dextromethorphan HBr

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "temporarily relieves common cold/flu symptoms: nasal congestion sinus congestion & pressure cough due to minor throat & bronchial irritation cough to help you sleep minor aches & pains headache fever sore throat runny nose & sneezing reduces swelling of nasal passages temporarily restores freer breathing through the nose promotes nasal and/or sinus drainage", "34068-7": "take only as directed do not exceed 8 Softgels per 24 hours adults & children 12 yrs & over 2 Softgels with water every 6 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use", "34071-1": "Liver warning This product contains acetaminophen. Severe liver damage may occur if you take more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product with other drugs containing acetaminophen 3 or more alcoholic drinks every day while using this product Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include: Skin reddening Blisters Rash If a skin 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.", "50565-1": "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.", "51727-6": "FD&C BLUE #1, GELATN, GLYCERIN, POLYETHYLENE GLYCOL, POVIDONE, PROPYLENE GLYCOL, PURIFIED WATER, SHELLAC, SORBITOL SORBITAN SOLUTION, TITANIUM DIOXIDE", "55105-1": "Pain reliever/Fever reducer Cough suppressant Antihistamine Nasal decongestant", "55106-9": "Acetaminophen PhenylephrineHCl, Doxylamine Succinate Dextromethorphan HBr"}

Kroger 626t Nighttme Severe Cold And Flu

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information