NDC | 49580-1434-4 |
Set ID | ad788820-1320-4e21-9b9f-82dc0e454335 |
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
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Warnings
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if your child takes:
• more than 5 doses in 24 hours, which is the
maximum daily amount
• with other drugs containing acetaminophen
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
• 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) • shake well before using
• find right dose on chart below. If possible, use
weight to dose; otherwise, use age
• if needed, repeat dose every 4 hours while
symptoms last
• do not give more than 5 times in 24 hours
Weight (lb) Age (yr) Dose (tsp or mL)
under 36 under 4 do not use
36-47 4-5 do not use unless directed by a doctor
48-95 6-11 2 tsps or 10 mL - Other Information
- Inactive Ingredients
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CHILDRENS PLUS MULTI-SYMPTOM COLD GRAPE WITH PE
childrens tylenol plus multi-symptom cold suspensionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49580-1434 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 160 mg in 5 mL CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 1 mg in 5 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 5 mg in 5 mL PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 2.5 mg in 5 mL Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) GLYCERIN (UNII: PDC6A3C0OX) WATER (UNII: 059QF0KO0R) D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C RED NO. 40 (UNII: WZB9127XOA) SODIUM BENZOATE (UNII: OJ245FE5EU) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) XANTHAN GUM (UNII: TTV12P4NEE) Product Characteristics Color Score Shape Size Flavor GRAPE (Grape Flavor) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49580-1434-4 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2009 12/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 01/01/2009 12/30/2021 Labeler - P & L Development, LLC (101896231)