说明与适用边界
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spl product data elements
DayTime High Blood Pressure Cold and Flu Relief Liquid filled Softgels Acetaminophen,Dextromethrophan HBR ACETAMINOPHEN ACETAMINOPHEN DEXTROMETHORPHAN HYDROBROMIDE DEXTROMETHORPHAN FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED POVIDONE PROPYLENE GLYCOL WATER SORBITOL SORBITAN TITANIUM DIOXIDE 609
活性成分 / Active ingredient
Drug Facts Active ingredients (in each Softgel) Acetaminophen 325 mg............. Pain reliever/Fever reducer Dextromethorphan HBr 10 mg..... Cough suppressant
适应证 / Indications and usage
Uses Temporarily relieves common cold/flu symptoms:
用途 / Purpose
• cough due to minor throat & bronchial irritation • sore throat • headache • minor aches & pain • fever
警告 / Warnings
Warnings Liver warning : This product contains acetaminophen. Severe liver damage may occur if you take•more than 8 softgels in 24 hours, which is the maximum daily amount for this product •with other drugs containing acetaminophen •3 or more alcoholic drinks daily while using this product. 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, lasts for more than 2 days, occurs with or is followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
禁用事项 / 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 •if you are now taking a prescription monoamine oxidase inhibitor (MAOI) (certain drugs for depression, psychiatric, or emotional conditions, or Parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your prescription drug contains an MAOI, ask a doctor or pharmacist before taking this product.
咨询医生 / Ask a doctor
咨询医药人员 / Ask a doctor or pharmacist
使用中 / When using
When using this product, do not use more than directed .
•When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing.
停用事项 / Stop use
Stop use and ask a doctor if •you get nervous, dizzy or sleepless •symptoms get worse or last more than 5 days (children) or 7 days (adults) •fever gets worse or lasts more than 3 days •redness or swelling is present •new symptoms occur •cough comes back or occurs with rash or headache that lasts. These could be signs of a serious condition.
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast feeding , ask a health professional before use.
儿童安全 / Keep out of reach of children
Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for aduits as well as for children, even if you do not notice any signs or symptoms.
用法用量原文 / Dosage and administration
Directions •take only as directed (see Warning) •do not exceed 4 doses per 24 hours Adults & Children 12 years & over : 2 soft gels with water every 4 hours Children 4 to under 12 years : Ask a doctor Children under 4 years : Do not use
其他安全资料 / Other safety information
Other information •store at room temperature 20-25°C (68-77°F) •avoid excessive heat
辅料 / Inactive ingredients
Inactive ingredients FD&C Red #40, FD&C Yellow #06, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water, Sorbitol sorbitan solution, titanium dioxide.
questions
Questions? Call Weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
package label principal display panel
Product Label: AP SAFE Daytime High Blood Pressure Cold/flu softgels ------------------------------------------------------ AP SAFE ® Daytime High Blood Pressure *Compare to the active ingredients Cold/Flu Relief In Vicks ® Dayquil High Blood Pressure Cold &Flu ® Acetaminophen Dextromethorphan HBr High Blood Pressure Cold/Flu Relief 24 Softgels Manufactured by AptaPharma Inc., 1533 Union Ave., Pennsauken, NJ 08110 • This product is not manufactured or distributed by Procter & Gamble, owner of the registered trademark Vicks ® Dayquil ™ High Blood Pressure Cold & Flu Liquicap ™ TAMPER EVIDENT:DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. Res 609
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 1 / 20260510
- 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.

