FDA label ad2a9db3-5b90-0f48-e053-2995a90ac010

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
ad2ab189-9672-3322-e053-2995a90ac9e5
SPL ID
ad2a9db3-5b90-0f48-e053-2995a90ac010
Version
1
Effective date
2020-08-18
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:25:11

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Warnings Liver warning - This product contains acetaminophen. Severe liver damage may occur if you take - more than 8sogtgels 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.

warnings

Warnings 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.

warnings table

<table border="0" width="100%"><tbody><tr><td><paragraph>Warnings <content styleCode="bold">Liver warning -</content> This product contains acetaminophen. Severe liver damage may occur if you take - more than 8sogtgels </paragraph><paragraph>This product contains acetaminophen.</paragraph><paragraph>Severe liver damage may occur if you take:</paragraph><list listType="unordered"><item>more than 8 Softgels in 24 hrs, which is the maximum daily amount for this product</item><item>with other drugs containing acetaminophen</item><item>3 or more alcoholic drinks every day while using this product</item></list><paragraph><content styleCode="bold">Allergy Alert:</content></paragraph><paragraph>Acetaminophen may cause severe skin reactions. Symptoms may include:</paragraph><list listType="unordered"><item>Skin reddening</item><item>Blisters</item><item>Rash</item></list><paragraph>If a skin reaction occurs, stop use and seek medical help right away</paragraph><paragraph><content styleCode="bold">Sore throat warning:</content></paragraph><paragraph>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.</paragraph></td></tr></tbody></table>

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.