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spl product data elements
Mommys Bliss Childrens Pain and Fever Acetaminophen SODIUM BENZOATE GLYCERIN CARBOXYMETHYLCELLULOSE SODIUM WATER ANHYDROUS CITRIC ACID SUCROSE XANTHAN GUM AMERICAN ELDERBERRY ACETAMINOPHEN ACETAMINOPHEN purple to brown liquid berry flavor
辅料 / Inactive ingredients
Inactive ingredients: anhydrous citric acid, glycerin, microcrystalline cellulose and carboxymethylcellulose sodium, natural flavors, organic elderberry juice concentrate, purified water, sodium benzoate, sucrose, xanthan gum
适应证 / Indications and usage
USE: Purpose: Pain reliever/fever reducer Uses temporarily: ▪ reduces fever ▪ relieves minor aches and pains due to: ▪ the common cold ▪ flu ▪ headache ▪ sore throat ▪ toothache
用法用量原文 / Dosage and administration
Directions and Dosing: 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 ▪ find right dose on chart below ▪ if possible, use weight to dose; otherwise, use age ▪ remove cap and seal, then insert the adapter plug by pushing down firmly until a tight seal is formed ▪ top of plug should be flush with bottle neck and not removeable ▪ squeeze dose into the provided dosing cup ▪ repeat dose every 4 hours while symptoms last ▪ do not give more than 5 times in 24 hours ▪ replace cap tightly to maintain child resistance Dosing: Weight (lb) Age (yr) Dose (mL)* under 24 lbs under 2 years ask a doctor 24-35 lbs 2-3 years 5 mL 36-47 lbs 4-5 years 7.5 mL 48-59 lbs 6-8 years 10 mL 60-71 lbs 9-10 years 12.5 mL 72-95 lbs 11 years 15 mL *or as directed by a doctor Attention: use only enclosed cup specifically designed for use with this product. Do not use any other dosing device.
警告和注意事项 / Warnings and precautions
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 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. 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. Ask a doctor before use if your child has liver disease Ask a doctor before use if your child is taking the blood thinning drug warfarin 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 ▪ redness or swelling is present ▪ any new symptoms appear These could be signs of a serious condition. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical even if you do not notice any signs or symptoms.
活性成分 / Active ingredient
Active ingredient: Active ingredient: (in each 5 mL) Acetaminophen 160mg
警告 / Warnings
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 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. 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. Ask a doctor before use if your child has liver disease Ask a doctor before use if your child is taking the blood thinning drug warfarin 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 ▪ redness or swelling is present ▪ any new symptoms appear These could be signs of a serious condition. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical even if you do not notice any signs or symptoms.
儿童安全 / Keep out of reach of children
Keep out of reach of Children. Keep out of reach of children. Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Prompt medical attention is critical even if you do not notice any signs or symptoms.
用途 / Purpose
Purpose and Use: Purpose: Pain reliever/fever reducer Uses temporarily: ▪ reduces fever ▪ relieves minor aches and pains due to: ▪ the common cold ▪ flu ▪ headache ▪ sore throat ▪ toothache
package label principal display panel
Children's Pain and Fever Acetaminophen 160mg per 5mL oral suspension Pain Reliever - Fever Reducer, 4 floz (118 mL) bottle in carton, Ages 2-11 years, Berry Flavor, Dosing Cup Included carton label flap
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 4 / 20240412
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.

