FDA Label for Cold Multi-symptom Nighttime
View Indications, Usage & Precautions
- 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
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- OVERDOSE WARNING
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- PRINCIPAL DISPLAY PANEL
Cold Multi-symptom Nighttime Product Label
The following document was submitted to the FDA by the labeler of this product American Sales Company. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
Drug Facts
Otc - Purpose
Active ingredients (in each caplet) | Purpose |
---|---|
Acetaminophen 325 mg | Pain reliever/fever reducer |
Chlorpheniramine maleate 2 mg | Antihistamine |
Dextromethorphan HBr 10 mg | Cough suppressant |
Phenylephrine HCl 5 mg | Nasal decongestant |
Uses
- temporarily relieves these common cold/flu symptoms:
- minor aches and pains
- headache
- sore throat
- nasal congestion
- runny nose and sneezing
- cough
- sinus congestion and pressure
- helps clear nasal passages
- relieves cough to help you sleep
- temporarily reduces fever
Liver Warning
This product contains acetaminophen. Severe liver damage may occur if you take
- more than 12 caplets in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
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 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.
Ask A Doctor Before Use If You Have
- liver disease
- high blood pressure
- diabetes
- heart disease
- thyroid disease
- glaucoma
- trouble urinating due to an enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- a breathing problem such as emphysema or chronic bronchitis
Ask A Doctor Or Pharmacist Before Use If You Are
- taking the blood thinning drug warfarin
- taking sedatives or tranquilizers
When Using This Product
- do not exceed recommended dosage
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives, and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when driving a motor vehicle or operating machinery
Stop Use And Ask A Doctor If
- nervousness, dizziness, or sleeplessness occur
- pain, nasal congestion, 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.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
Overdose Warning
Taking more than the recommended dose (overdose) may cause liver damage. 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.
Directions
- do not take more than directed (see overdose warning)
- take 2 caplets every 4 hours
- swallow whole – do not crush, chew, or dissolve
- do not take more than 12 caplets in 24 hours
- do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
adults and children 12 years and over | |
children under 12 years |
Other Information
- store between 20°-25°C (68°-77°F) in a dry place
- retain carton for complete product information
Inactive Ingredients
acesulfame potassium, colloidal silicon dioxide, croscarmellose sodium, FD&C blue #1, flavor, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized starch, propylene glycol, stearic acid, talc, titanium dioxide
Principal Display Panel
Compare to the Active Ingredients in Tylenol® Cold Multi-Symptom Nighttime†
CareOne®
Nighttime
Cold Multi-Symptom
Pain Reliever/Fever Reducer, Antihistamine
Cough Suppressant, Nasal Decongestant
Fever/Headache/ Sore Throat
Acetaminophen
Runny Nose
Chlorpheniramine Maleate
Coughing
Dextromethorphan HBr
Nasal Congestion
Phenylephrine HCl
Instant Cooling Sensation
See New Warnings Information
24 Caplets
* Please review the disclaimer below.