Otc - Active Ingredient
Acetaminophen 325mg
Foster And Thrive Regular Strength Pain Relief Acetaminophen 325mg Tablet
FDA Label NDC 70677-1302
16 label sections · Submitted to the FDA by Strategic Sourcing Services Llc · Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Strategic Sourcing Services Llc for the product Foster And Thrive Regular Strength Pain Relief Acetaminophen 325mg (NDC 70677-1302). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, indications & usage, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - stop use, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - Purpose
Pain reliever/fever reducer
Indications & Usage
■ temporarily relieves minor aches and pains due to:
- the common cold
- headache
- backache
- minor pain of arthritis
- toothache
- muscular aches
- premenstrual and menstrual cramps
■ temporarily reduces fever
Warnings
Warnings
Liver warning: This product contains acetaminophen. The maximum daily dosage for this product is
10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children 6–12
years of age.
Severe liver damage may occur if
■ adult takes more than 4,000 mg of acetaminophen in 24 hours
■ child takes more than 5 doses in 24 hours, which is the maximum daily amount
■ taken with other drugs containing acetaminophen
■ adult has 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
Otc - 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 are allergic to acetaminophen or any of the inactive ingredients in this product
Otc - Ask Doctor
Ask a doctor before use if the user ■ has liver disease ■ is a child with pain of arthritis
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the user is taking the blood thinning
drug warfarin.
Otc - Stop Use
Stop use and ask a doctor if
■ pain gets worse or lasts more than 10 days in adults
■ pain gets worse or lasts more than 5 days in children under 12 years
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present.
These could be signs of a serious condition
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
Overdose warning
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.
Dosage & Administration
Directions
■ do not take more than directed (see overdose warning)
| adults and children 12 years and over | ■ take 2 tablets every 4 to 6 hours while symptoms last
■ do not take more than 10 tablets in 24 hours, unless directed by a doctor ■ do not use for more than 10 days unless directed by a doctor |
| children 6 years to under 12 years | ■ take 1 tablet every 4 to 6 hours while symptoms last
■ do not take more than 5 tablets in 24 hours ■ do not use for more than 5 days unless directed by a doctor |
| children under 6 years | ask a doctor |
Other Safety Information
Other information
■ store between 20–25°C (68–77°F)
Inactive Ingredient
Inactive ingredients
hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol,
polyvinylpyrrolidone, pre-gelatinized starch, stearic acid, talc, titanium dioxide.
Otc - Questions
Questions or comments? Call 833-358-6431 Mon to Fri 9:00am to 7:00pm EST
Package Label.Principal Display Panel
PRINCIPLE DISPLAY PANEL
Pdp (Foster Thrive Pain Relief Label)
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