Label: TYLO EXTRA (ACETAMINOPHEN)- acetaminophen tablet, delayed release
- NDC Code(s): 49638-112-30
- Packager: America Medic & Science, 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.
Updated January 22, 2019
If you are a consumer or patient please visit this version.
- Tylo Extra 1000 mg
- Active Ingredient
Acetaminophen 1000 mgClose
Pain reliever/fever reducerClose
- temporarily relieves minor aches and pains due to:
- minor pain of arthritis
- temporarily reduces fever
- the common cold
- menstrual cramps
- muscular aches
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.
- Do not use
- with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you have ever had an allergic reaction to acetaminophen or any of the inactive ingredients in this product.
- ASK DOCTOR
Ask a doctor before use if you have liver diseaseClose
- ASK DOCTOR/PHARMACIST
Ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarinClose
- STOP USE
Stop use and ask a doctor if
- pain gets worse or lasts more than 10 days
- fever gets worse or lasts more than 3 days
- new symptoms appear
- redness or swelling is present
These could be signs of a serious conditionClose
- PREGNANCY OR BREAST FEEDING
If pregnant or breast-feeding, ask a health professional before use.Close
- KEEP OUT OF REACH OF CHILDREN
Keep out of reach of children.Close
- Overdose warning
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. (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.Close
do not take more than directed (see overdose warning).
Adults and children 12 years and over:
- take 1 caplet every 6 to 8 hours
- Do not take more than 4 caplets of this product in 24 hours.
Children under 12 years:
- do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.
- Other information
- store between 20-25°C (68-77°F)
- see end panel for lot number and expiration date
- Inactive ingredients
- Carnauba wax, hypromellose, polyethylene glycol, propylene glycol, povidone, pregelatinized starch, stearic acid, titanium dioxide
- Questions or comments?
call toll free 1-855-470-6722Close
- PRINCIPAL DISPLAY PANEL
Tylo Extra 1000 mg
- INGREDIENTS AND APPEARANCE
TYLO EXTRA (ACETAMINOPHEN)
acetaminophen tablet, delayed release
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49638-112 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg Inactive Ingredients Ingredient Name Strength CARNAUBA WAX (UNII: R12CBM0EIZ) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color white Score no score Shape capsule Size 8mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49638-112-30 1 in 1 CARTON 01/17/2019 1 24 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 01/17/2019 Labeler - America Medic & Science, LLC (071065464) Registrant - America Medic & Science, LLC (071065464) Establishment Name Address ID/FEI Business Operations Time Cap Laboratories, Inc 037052099 manufacture(49638-112)