Otc - Active Ingredient
Drug Facts
Active ingredients
(in each Softgel)
Acetaminophen 325 mg............. Pain reliever/Fever reducer
Dextromethorphan HBr 15 mg..... Cough suppressant
Doxylamine succinate 6.25 mg ..... Antihistamine
The following Structured Product Label (SPL) was submitted to the FDA by Aptapharma Inc. for the product Night Time Cold And Flu Relief Liquid Filled Softgels (NDC 76281-603). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, indications & usage, otc - purpose, warnings, otc - do not use, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Drug Facts
Active ingredients
(in each Softgel)
Acetaminophen 325 mg............. Pain reliever/Fever reducer
Dextromethorphan HBr 15 mg..... Cough suppressant
Doxylamine succinate 6.25 mg ..... Antihistamine
Uses
Temporarily relieves common cold/flu symptoms:
• cough due to minor throat & bronchial irritation
• sore throat
• headache
• minor aches & pain
• fever
• runny nose & sneezing
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take: •more than 4 doses 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.
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 •to make a child sleep
Ask a doctor before use if you have
• liver disease •glaucoma •cough that occurs with too much phlegm (mucus)
• a breathing problem or chronic cough that lasts or as occurs with smoking, asthma, chronic bronchitis or emphysema
• trouble urinating due to enlarged prostate gland
Ask a doctor or pharmacist before use if you are •taking sedatives or tranquilizers •taking the blood thinning drug
warfarin
When using this product do not use more than directed.• excitability may occur, especially in children,
• marked drowsiness may occur •avoid alcoholic drinks •be careful when driving a motor vehicle or operating
machinery •alcohol, sedatives, and tranquilizers may increase drowsiness
•When using other Daytime or Nighttime products, carefully read each label to ensure correct dosing.
Stop use and ask a doctor if
•pain or cough gets worse or lasts more than 7 days •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.
If pregnant or breast feeding, ask a health professional before use.
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.
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 6 hours
Children 4 to under 12 years: Ask a doctor
Children under 4 years: Do not use
Other information
•Store at room temperature 20-25°C (68-77°F)
•avoid excessive heat
Inactive ingredients
D&C Yellow # 10, FD&C Blue # 1, gelatin, glycerin, polyethylene glycol, povidone, propylene glycol, purified water,
Sorbitol sorbitan solution, Titanium dioxide.
Questions? Call Weekdays from 9:30 AM to 4:30 PM EST at 1-877-798-5944
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AP SAFE® Nighttime *Compare to the active ingredients
Cold/Flu Relief In Vicks® Nyquil™ Cold & Flu Nighttime
Relief LiquiCaps™
Acetaminophen
Dextromethorphan HBr/Doxylamine Succinate
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® Nyquil™ Liquicaps™
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 WARNING AND PRODUCT INFORMATION.
resRes
* Please review the disclaimer below.