![GOOD SENSE PAIN RELIEFCHILDRENS CHILDRENS (ACETAMINOPHEN) SUSPENSION [AIDAREX PHARMACEUTICALS LLC]](https://medic.hrt.org//dailymed/images/45ddd71d-de6c-4e21-a22a-0b37afcc429b/acetaminophen-160-mg-for-perrigo-1.jpg)
| NDC | 33261-770-01 |
| Set ID | 45ddd71d-de6c-4e21-a22a-0b37afcc429b |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Aidarex Pharmaceuticals LLC |
| Generic Name | |
| Product Class | |
| Product Number | |
| Application Number | PART343 |
- Active ingredient (in each 5 mL = 1 teaspoon)
- Purpose
- Uses
-
Warnings
Liver warning: 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
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 has ever had an allergic reaction to this product or any of its ingredients
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.
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. (1-800-222-1222) Quick medical attention is critical even if you do not notice any signs or symptoms.
-
Directions
- •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 right dose on chart. If possible, use weight to dose; otherwise, use age.
- •remove the children protective cap and squeeze your child’s dose into the dosing cup
- •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)*
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 ( 1 ½ tsp)
48-59
6-8 years
10 mL (2 tsp)
60-71
9-10 years
12.5 mL (2 ½ tsp)
72-95
11 years
15 mL (3 tsp)
*or as directed by a doctor
Attention: use only enclosed dosing cup specifically designed for use with this product. Do not use any other dosing device.
- Other information
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Inactive ingredients
anhydrous citric acid, butylparaben, calcium sulfate, carrageenan, D&C red #33, FD&C blue #1, flavor, glycerin, high fructose corn syrup, hydroxyethyl cellulose, microcrystalline cellulose and carboxymethylcellulose sodium, propylene glycol, purified water, sodium benzoate, sorbitol solution, tribasic sodium phosphate
- Questions or comments?
-
Principal Display Panel
For Ages 2 – 11
Children’s
Pain Relief
Acetaminophen Oral Suspension
Fever Reducer/Pain Reliever
Suspension Liquid
Alcohol Free
Aspirin Free
Ibuprofen Free
Grape Flavor
Compare to active ingredient of Children’s Tylenol® Oral Suspension
160 mg per 5 mL
Repackaged By :
Aidarex Pharmaceuticals LLC,
Corona, CA 92880 -
INGREDIENTS AND APPEARANCE
GOOD SENSE PAIN RELIEFCHILDRENS CHILDRENS
acetaminophen suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:33261-770(NDC:0113-0130) 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 ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) BUTYLPARABEN (UNII: 3QPI1U3FV8) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CARRAGEENAN (UNII: 5C69YCD2YJ) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GLYCERIN (UNII: PDC6A3C0OX) HIGH FRUCTOSE CORN SYRUP (UNII: XY6UN3QB6S) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) CALCIUM SULFATE (UNII: WAT0DDB505) SODIUM PHOSPHATE, TRIBASIC (UNII: A752Q30A6X) Product Characteristics Color PURPLE (viscous) Score Shape Size Flavor GRAPE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:33261-770-01 1 in 1 CARTON 1 118 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part343 02/25/1993 Labeler - Aidarex Pharmaceuticals LLC (801503249)