![COLD AND COUGH NIGHTTIME COOL BLAST (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE) LIQUID [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)]](https://medic.hrt.org//dailymed/images/c9f6d719-1780-4366-8f1f-67a28227f402/cold-cough-nighttime-cool-blast-liquid-delisted-1.jpg)
| NDC | 63868-065-08 |
| Set ID | c9f6d719-1780-4366-8f1f-67a28227f402 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | QUALITY CHOICE (Chain Drug Marketing Association) |
| Generic Name | |
| Product Class | Antihistamine |
| Product Number | |
| Application Number | PART341 |
- Active ingredients (in each 30 mL, 2 tablespoons)
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses (8 tablespoons or 120 mL) in 24 hours, which is the maximum daily amount
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks everyday 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
- 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
- glaucoma
- liver disease
- cough that occurs with too much phlegm (mucus)
- breathing problems such as emphysema or chronic bronchitis
- persistent or chronic cough such as occurs with smoking, asthma, or emphysema
- trouble urinating due to an enlarged prostate gland
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)
- marked drowsiness may occur
- avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- be careful when driving a motor vehicle or operating machinery
- excitability may occur, especially in children
Stop use and ask a doctor if
- redness or swelling is present
- new symptoms occur
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- 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) immediately. 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)
- use dosage cup provided. Do not use any other dosing device.
- tbsp - tablespoon, mL = milliliter
age dose adults and children 12 years and over - take 2 tablespoons (30 mL) in dose cup provided every 6 hours
- do not take more than 8 tablespoons (120 mL) in 24 hours
children under 12 years - 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
- Other information
- Inactive ingredients
- Questions or comments?
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Principal Display Panel
*Compare to the active ingredients in Tylenol® Cold & Cough Night Time
Nighttime Cold & Cough
Cool Blast
Acetaminophen - Pain Reliever/Fever Reducer
Dextromethorphan HBr - Cough Suppressant
Doxylamine Succinate - Antihistamine
For Ages 12 & Over
Distributed by C.D.M.A., Inc.
43157 W. Nine Mile
Novi, MI 48379-0995
www.qualitychoice.com
Questions: 248-449-9300
TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL IS BROKEN OR MISSING.
*This product is not manufactured or distributed by McNeil Consumer & Specialty Pharmaceuticals, distributor of Tylenol® Cold & Cough Nighttime.
PARENTS: Learn about teen medicine abuse www.StopMedicineAbuse.org
- Product Label
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INGREDIENTS AND APPEARANCE
COLD AND COUGH NIGHTTIME COOL BLAST
acetaminophen, dextromethorphan hydrobromide, doxylamine succinate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-065 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 1000 mg in 30 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 30 mg in 30 mL DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 12.5 mg in 30 mL Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) Product Characteristics Color BLUE (Clear) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-065-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 06/30/2014 12/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 06/30/2014 12/30/2021 Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)
