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TAMPER EVIDENT:
DO NOT USE IF PRINTED SHRINKBAND SEAL AROUND THE NECK IS BROKEN OR MISSING.
DIST. BY:
PROCTER & GAMBLE
CINCINNATI, OH 45202
Vicks Nyquil Liquid
FDA Label NDC 84126-374
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by The Procter & Gamble Manufacturing Company for the product Vicks Nyquil (NDC 84126-374). 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 other, active ingredients (in each 15 ml), purpose, uses, warnings, do not use, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Active Ingredients (In Each 15 Ml)
Acetaminophen 325 mg
Doxylamine succinate 6.25 mg
Purpose
Pain reliever/fever reducer
Antihistamine
Uses
temporarily relieves common cold/flu symptoms:
- sore throat
- headache
- minor aches & pains
- fever
- runny nose & sneezing
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if
- adult takes more than 4 doses (30 mL each) in 24 hrs, which is the maximum daily amount for this product
- child takes more than 4 doses (15 ml each) in 24 hrs, which is the maximum daily amount for this product
- taken with other drugs containing acetaminophen
- adult has 3 or more alcoholic drinks every day while using this product
- skin reddening
- blisters
- rash
Allergy Alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
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.
Ask A Doctor Before Use If You Have
- liver disease
- glaucoma
- a breathing problem or chronic bronchitis or emphysema
- trouble urinating due to enlarged prostate gland
- a sodium-restricted diet
Ask A Doctor Or Pharmacist Before Use If You Are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When Using This Product
- 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
Stop Use And Ask A Doctor If
- pain gets worse or lasts more than 5 days (children) or 10 days (adults)
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
These could be signs of a serious condition.
If Pregnant Or Breast-Feeding,
ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away. Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Directions
• take only as directed
• only use the dose cup provided
• do not exceed 4 doses per 24 hrs
| adults & children 12 yrs & over | 30 mL per dose every 4 hrs |
| children 6 to under 12 yrs | 15 mL every 4 hrs |
| children 4 to under 6 yrs | ask a doctor |
| children under 4 yrs | do not use |
Other Information
- each 15 mL contains: sodium 44 mg
- store at no greater than 25°C (77°F) and do not refrigerate
Inactive Ingredients
anhydrous citric acid, FD&C Blue No, 1, FD&C Red No. 40, flavor, glycerin, propylene glycol, saccharin sodium, sodium benzoate, sodium chloride, sorbitol, sucralose, trisodium citrate dihydrate, water, xanthan gum
Questions?
1-800-362-1683
Principal Display Panel - 236 Ml Bottle Label
VICKS ®
NyQuil™
SINUS
PAIN & HEADACHE
Acetaminophen -Pain Reliever/Fever Reducer
Doxylamine Succinate - Antihistamine
Sinus Pain & Headache
runny Nose & Sneezing
Cooling Sensation
Nighttime Relief
8 FL OZ (354 mL)
374 (374)
* Please review the disclaimer below.
