NDC | 61715-074-08 |
Set ID | 08dadb5c-38e2-41e2-9963-83f98025330a |
Category | HUMAN OTC DRUG LABEL |
Packager | Kinray LLC |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist, Antihistamine |
Product Number | |
Application Number | PART341 |
- Active ingredients (in each 15 mL tablespoon)
- Purpose
- Uses
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Warnings
Alcohol Warning: if you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Acetaminophen or oter pain releivers/ fever reducers.
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you take:
- more than 4 doses in 24 hours, which is the maximum daily amount of this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day 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
- with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
- 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.
- to make a child sleep
- if you are allergic to acetaminophen or any of the ingredients in this product.
Ask a doctor before use if you have
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough such as occurs with smoking, asthma, chronic bronchitis, or emphysema
- a sodium-restricted diet
Ask a doctor or pharmacist before use if you are
- taking sedatives or tranquilizers
- taking the blood thinning drug warfarin
When using this product do not use more than directed
- excitability may occur, especially in children
- marked drowsiness may occur
- alcohol, sedatives and tranquilizers may increase drowsiness
- avoid alcoholic drinks
- be careful when operating machinery
Stop use and ask a doctor if
- pain or cough gets worse or lasts more than 7 days
- fever gets worse or lasts more than 3 days
- redness or swelling is present
- new symptoms occur
- 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 recommended dose can cause serious health problems. In case of overdose, get medical help or contact a Poison Control Center right away. Prompt 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
- take only as recommended - see overdose warning
- use dose cup or Tabelspoon (TBSP)
- do not take more than 10 tablespoons (tbsp) or 150 mL in 24-hours period
Adults and
children 12 years of age
and over- take 2 tablespoons (tbsp) 30 ml in dose cup provided every 6 hours as needed
Children under 12 years - do not use this 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?
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
COUGH MULTI SYMPTOM
acetaminophen, dextromethorphan hbr, doxylamine succinate, phenylephrine hcl liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61715-074 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg in 15 mL DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 15 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 CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) MENTHOL (UNII: L7T10EIP3A) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SODIUM BENZOATE (UNII: OJ245FE5EU) SACCHARIN SODIUM (UNII: SB8ZUX40TY) SORBITOL (UNII: 506T60A25R) SUCROSE (UNII: C151H8M554) Product Characteristics Color BLUE (clear) Score Shape Size Flavor MENTHOL Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61715-074-08 236 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/28/2006 Labeler - Kinray LLC (012574513)