NDC | 49580-0192-8 |
Set ID | 7d7cbf19-6533-4788-8dc8-e8bb9d116447 |
Category | HUMAN OTC DRUG LABEL |
Packager | P & L Development, LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active Ingredients
- Purposes
- Uses
- Warnings
-
Do Not Use
• to make a child sleepy
• in a child who is 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 child's
prescription drug contains an MAOI, ask a doctor
or pharmacist before giving 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. - Ask a doctor before use if the child has
- Ask a doctor or pharmacist before use if the child is taking
- When using this product
-
Stop use and ask a doctor if
• new symptoms occur
• fever gets worse or lasts for more than 3 days
• redness or swelling is present
• pain, nasal congestion or cough gets worse or
lasts for more than 5 days
• nervousness, dizziness or sleeplessness occur
• cough comes back or occurs with rash or headache
that lasts. These could be signs of a serious
condition -
Keep this and all drugs out of the reach of children.
Overdose Warning: Taking more than the
recommended dose (overdose) could cause serious
health problems, including liver damage. In case of
accidental overdose, seek professional assistance or
contact a Poison Control Center immediately. Quick
medical attention is critical even if you do not notice
any signs or symptoms. -
Directions
• do not exceed recommended dosage
(see overdose warning) Use the dosage cup provided
Age (yr) Dose (tsp or mL)
children under the age of 12; this will provide more do not usethis product on children under 12 years of agethan the recommended dose (overdose) and may
cause liver damage
Adults and children 12 years of age and older: Take 2 tbsp (30mL) in dosage cup provided every 4 hours
Do not take more than 12 tbsp (180mL) in 24 hours
- Other Information
- Inactive Ingredients
-
Principal Display Panel
Cold Multi-Symptom Cool Blast
Daytime
Acetaminophen Fever and sore throat
Dextromethorphan HBr Cough
Guaifenesin Chest congestion
Phenylephrine HCI stuffy nose
For ages 12 and over
alcohol .5 percent
Compare to active ingredient in Tylenol Cold multi-symptom daytime
Manufactured by Aaron Industries, Inc PO box 801 Lynwood CA 90262
8 fl oz 237mL
-
INGREDIENTS AND APPEARANCE
DAY TIME COLD MULTI-SYMPTOM COOL BLAST
tylenol multi symptom cool blast daytime liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-0192 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg in 5 mL GUAIFENESIN (UNII: 495W7451VQ) (GUAIFENESIN - UNII:495W7451VQ) GUAIFENESIN 200 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 5 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCRALOSE (UNII: 96K6UQ3ZD4) Product Characteristics Color Score Shape Size Flavor MINT (Mint Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-0192-8 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2010 12/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 01/01/2010 12/30/2021 Labeler - P & L Development, LLC (101896231)