Other
Drug Facts
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.
The following Structured Product Label (SPL) was submitted to the FDA by Kenvue Brands Llc for the product Tylenol Cold Plus Flu Multi-symptom Gels Night (NDC 50580-131). 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, otc - purpose, uses, liver warning, sore throat warning, 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.
Drug Facts
Allergy alert: acetaminophen may cause severe skin reactions. Symptoms may include:
If a skin reaction occurs, stop use and seek medical help right away.
| Active ingredients (in each capsule) | Purpose |
|---|---|
| Acetaminophen 325 mg | Pain reliever/fever reducer |
| Dextromethorphan HBr 15 mg | Cough suppressant |
| Doxylamine Succinate 6.25 mg | Antihistamine |
■ temporarily relieves these common cold/flu symptoms:
■ minor aches and pains
■ headache
■ sore throat
■ cough
■ runny nose and sneezing
■ temporarily reduces fever
This product contains acetaminophen. Severe liver damage may occur if you take
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.
■ liver disease
■ glaucoma
■ a breathing problem such as emphysema or chronic bronchitis
■ trouble urinating due to an enlarged prostate gland
■ persistent or chronic cough such as occurs with smoking, asthma or emphysema
■ cough that occurs with too much phlegm (mucus)
■ 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 overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
| adults and children 12 years and over | ■ take 2 capsules every 6 hours while symptoms last ■ do not take more than 8 capsules in 24 hours |
| children 4 to under 12 years | ask a doctor |
| children under 4 years | do not use |
■ store between 20-25°C (68-77°F)
■ avoid high humidity and excessive heat above 40°C (104°F)
■ protect from light
■ do not use if blister unit is torn or broken
D&C yellow no. 10, FD&C blue no. 1, gelatin, glycerin, lecithin, mineral oil, polyethylene glycol, povidone, propylene glycol, purified water, sorbitol sorbitan solution
call 1-877-895-3665 (toll-free) or 215-273-8755 (collect)
NDC 50580-131-24
NEW
TYLENOL
®
FOR ADULTS
COLD & FLU
MULTI-SYMPTOM
LIQUID GELS
Acetaminophen, Dextromethorphan HBr, Doxylamine Succinate
Pain Reliever–Fever Reducer, Cough Suppressant, Antihistamine
NIGHT
• HEAD + BODY ACHES
• FEVER + SORE THROAT
• COUGH
• RUNNY NOSE
*LIQUID FILLED CAPSULES
Actual Size
24 LIQUID GELS*
* Please review the disclaimer below.