Label: BACTIMICINA CHILDRENS PAIN AND FEVER- acetaminophen liquid
- NDC Code(s): 24286-1550-4
- Packager: DLC Laboratories, Inc.
- 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 November 9, 2018
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each 5 mL = 1 teaspoonful)
This product contains acetaminophen. Severe liver damage may occur if your child takes
- more than 5 doses in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
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.
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 your child is allergic to acetaminophen or any of the inactive ingredients in this product
When using this product do not exceed recommended dose (see overdose warning)
Stop use and ask a doctor if
- pain gets worse or lasts more than 5 days
- 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.
- Overdose warning
- this product does not contain directions or complete warnings for adult use
- do not give more than directed (see overdose warning)
- shake well before using
- mL = milliliter; tsp = teaspoonful
- find the right dose on chart below. If possible, use weight to dose; otherwise, use age.
- repeat dose every 4 hours while symptoms last
- do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (mL or tsp)*
- or as directed by a doctor
Under 24 Under 2 years Ask a doctor 24-35 2-3 years 5 mL (1 tsp) 36-47 4-5 years 7.5 mL (1½ tsp) 48-59 6-8 years 10 mL (2 tsp) 60-71 9-10 years 12.5 mL (2½ tsp) 72-95 11 years 15 mL (3 tsp)
Attention: use only enclosed dosage cup specifically designed for use with this product. Do not use any other dosing device.
- Other information
- Inactive ingredients
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
INGREDIENTS AND APPEARANCE
BACTIMICINA CHILDRENS PAIN AND FEVER
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:24286-1550 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL Inactive Ingredients Ingredient Name Strength CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C RED NO. 40 (UNII: WZB9127XOA) CORN SYRUP (UNII: 9G5L16BK6N) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) GLYCERIN (UNII: PDC6A3C0OX) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor CHERRY (Cherry Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:24286-1550-4 1 in 1 BOX 11/17/2014 1 118 mL 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 11/17/2014 Labeler - DLC Laboratories, Inc. (093351930) Establishment Name Address ID/FEI Business Operations DLC Laboratories, Inc. 093351930 MANUFACTURE(24286-1550) , LABEL(24286-1550)