![COLD MAX NIGHTTIME (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCI) LIQUID [P & L DEVELOPMENT, LLC]](https://medic.hrt.org//dailymed/images/dac0d878-2288-4b55-8691-7f9f16e6d341/cold-max-nighttime-cool-blast-liquid-1.jpg)
| NDC | 49580-0515-8 |
| Set ID | dac0d878-2288-4b55-8691-7f9f16e6d341 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | P & L Development, LLC |
| Generic Name | |
| Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 15 mL)
- Purpose
- Uses
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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.
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.
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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
- Inactive ingredients
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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
- Product Label
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INGREDIENTS AND APPEARANCE
COLD MAX NIGHTTIME
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate, phenylephrine hci liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0515 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 15 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg in 15 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 15 mL Inactive Ingredients Ingredient Name Strength ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) ALCOHOL (UNII: 3K9958V90M) Product Characteristics Color BLUE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0515-8 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 10/31/2016 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 10/31/2016 Labeler - P & L Development, LLC (101896231)
