COLD MAX NIGHTTIME- acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquid
P & L Development, LLC
Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
----------
Active ingredients (in each 15 mL)
Acetaminophen 325 mg
Dextromethorphan HBr 10 mg
Doxylamine succinate 6.25 mg
Phenylephrine HCI 5 mg
Purpose
Pain reliever/fever reducer
Cough suppressant
Antihistamine
Nasal decongestant
Uses
- temporarily relieves these common cold/flu symptoms
- minor aches and pains
- headache
- nasal congestion
- sore throat
- runny nose and sneezing
- cough
- sinus congestion and pressure
- helps clear nasal passages
- relieves cough to help you sleep
- temporarily reduces fever
Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4,000 mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday 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, persists for more than 2 days, is accompanied or followed by fever, headache, rash, nausea or vomiting, consult a doctor promptly.
Do not use
-
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.
- with any other drug containing acetaminophen (prescription or non-prescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- if you are allergic to acetaminophen or any of the inactive ingredients in this product
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- glaucoma
- trouble urinating due to enlarged prostate gland
- 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
Ask a doctor or pharmacist before use if you are taking
- sedatives or tranquilizers
- the blood thinning drug warfarin
When using this product
-
do not exceed recommended dose (see overdose warning)
- excitability may occur, especially in children
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- 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
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- 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.
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 (1-800-222-1222) 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
- do not take more than directed (see Overdose warning)
- do not take more than 6 doses in any 24-hour period
- measure only with dosing cup provided. Do not use any other dosing device.
- mL = milliliter
- keep dosing cup with product
- adults and children 12 years and over: 30 mL every 4 hours
- children under 12 years of age: do not use
Other information
-
each 15 mL contains: sodium 3 mg
- store between 20-25ºC (68-77ºF). Do not refrigerate.
Inactive ingredients
citric acid, ethyl alcohol, FD&C blue #1, flavors, propylene glycol, purified water, sodium benzoate, sorbitol, sucralose
Principal Display Panel
*Compare to the active ingredients in Tylenol® Cold Max Nighttime Cool Burst
nighttime
cold max
Acetaminophen
dextromethorphan HBr
doxylamine Succinate
phenylephrine HCI
For ages 12 years and over
alcohol 0.5%
cool blast flavor
relieves:
- head & body aches
- fever & sore throat
- cough
- nasal congestion
- runny nose & sneezing
*This product is not manufactured or distributed by McNeil Consumer Healthcare, distributor of Tylenol®Cold Max Nighttime Cool Burst®.
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL AROUND DOSAGE CUP OR UNDER CAP IS BROKEN OR MISSING.
Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
Manufactured by:
PL Developments
11865 S. Alameda St
Lynwood, CA 90262