Label: ACETAMINOPHEN 325 MG- acetaminophen tablet
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- NDC Code(s): 69618-010-01, 69618-010-10
- Packager: Reliable 1 Laboratories LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated October 1, 2015
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
- temporarily relieves minor aches and pains due to:
- headache
- muscular aches
- backache
- minor pain of arthritis
- the common cold
- toothache
- premenstrual or menstrual cramps
- temporarily reduces fever
- Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4,000 mg in 24 hours, which is the maximum daily amount
- child takes more than 5 tablets in 24 hours, which is the maximum daily amount
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks while using this product
- OTHER SAFETY INFORMATION
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.
Close - 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.
Close - ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- 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
- 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.
Close - PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.
Overdose warning: Taking more than the recommended dose (overdose) may cause liver damage. 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.
Close - Directions
- do not take more than directed (see overdose warning)
Closeadults and children 12 years and over take 2 tablets every 4-6 hours while symptoms last, not more than 12 tablets in 24 hours children 6 to 11 years take 1 tablet every 4-6 hours while symptoms last, not more than 5 tablets in 24 hours children under 6 years do not use - Other information
- Inactive ingredients
- Questions or comments?
- SPL UNCLASSIFIED SECTION
- SPL UNCLASSIFIED SECTION
*Reliable 1 Laboratories LLC is not affiliated with the owner of the trademark Tylenol®.
Distributed by: Reliable 1 Laboratories LLC, Valley Stream, NY 11580
www.reliable1labs.com
Close - PRINCIPAL DISPLAY PANEL
NDC 69618-010-01
Regular Strength
Acetaminophen USP 325 mg
PAIN RELIEVER
FEVER REDUCER
100 TABLETS
*Compare to Active Ingredient in Regular Strength TYLENOL®
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- INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 325 MG
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69618-010 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg Inactive Ingredients Ingredient Name Strength STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) STEARIC ACID (UNII: 4ELV7Z65AP) POVIDONE (UNII: FZ989GH94E) Product Characteristics Color white Score no score Shape ROUND Size 8mm Flavor Imprint Code AP;012 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69618-010-01 100 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2015 2 NDC:69618-010-10 1000 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 11/01/2015 
Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 11/01/2015 CloseLabeler - Reliable 1 Laboratories LLC (079718111)