NDC | 69619-303-10 |
Set ID | f78fdf84-5ed2-49ce-bc9b-e31663bdc92a |
Category | HUMAN OTC DRUG LABEL |
Packager | A&Z Holistic Products, Inc. |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENTS (IN EACH SOFTGEL)
- PURPOSES
- USES
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WARNINGS
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 for 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 product 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 drugs. If you do not know if your prescription contains an MAOI, ask a doctor or pharmacist before taking this product.
Ask a doctor before use if you have
- liver disease
- heart disease
- thyroid disease
- diabetes
- high blood pressure
- trouble urinating due to enlarged prostate gland
- cough that occurs with too much phlegm (mucus)
- persistent or chronic cough as occurs with smoking, asthma, or emphysema
Stop use and ask a doctor if
- you get nervous, dizzy or sleepless
- symptoms get worse or last more than 5 days (children) or 7 days (adults)
- 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: In case of accidental overdose, contact a doctor or Poison Control Center immediately (1-800-222-1222). Taking more than the recommended dose (overdose) may cause liver damage. Quick medical attention is critical for adults as well as for children, even if you do not notice any signs or symptoms.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS OR COMMENTS?
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
DAYTIME COLD AND FLU RELIEF
acetaminophen, dextromethorphan hbr, phenylephrine hci capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69619-303 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) FD&C RED NO. 40 (UNII: WZB9127XOA) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) SORBITOL (UNII: 506T60A25R) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Product Characteristics Color orange (amber) Score no score Shape OVAL Size 20mm Flavor Imprint Code 534 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69619-303-10 1 in 1 BOX 03/24/2016 1 10 in 1 BLISTER PACK; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 03/24/2016 Labeler - A&Z Holistic Products, Inc. (079721290) Registrant - A&Z Holistic Products, Inc. (079721290) Establishment Name Address ID/FEI Business Operations Anshi Pharmaceutical (Zhongshan) Inc. 528101821 manufacture(69619-303)