NDC | 58805-003-04, 58805-003-14 |
Set ID | 0c3a89d3-9b88-4cc4-bc0e-a95a95824309 |
Category | HUMAN OTC DRUG LABEL |
Packager | Agile Pharmachem |
Generic Name | |
Product Class | Antihistamine |
Product Number | |
Application Number | PART341 |
- Active Ingredient
(in each softgel)
Acetaminophen 325 mg
Dextromethorphan HBr 15 mg
Doxylamine Succinate 6.25 mg
Close - Purpose
- Uses
- Warnings
Warnings Failure to follow these warnings could result in serious consequences.
Liver Warning: This product contains acetaminophen. Severe liver damage may occur if you take
- more than 4 doses in 24 hours which is maximum daily amount for this product
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks daily while using this product
do not use:
- with any other drug containing acetaminophen (prescription or not prescription). 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.
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
-
ask your doctor or pharmacist before use if you are taking the blood thinning drug warfarin. When using this product, do not use more than directed.
-
Stop use and ask a doctor if:
- Redness or swelling is present
- You get nervous, dizzy or sleepless
- Fever gets worse or lasts more than 3 days
- New symptoms occur
- Symptoms do not get better within 7 days or are accompanied by a fever
- Keep out of reach of children.
If pregnant or breast-feeding, ask a health professional before use.
Overdose warning: Taking more than recommended dose (overdose) may cause liver damage. 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.
Tamper evident: this package is safety sealed and child resistant. Use only if blisters are intact. If difficult to open use scissors.
Close - Direction
- do not exceed 4 doses per 24 hours
- take only as directed – see overdose warning
- Adults and children 12 years and over: 2 softgels with water every 4 hours
- children under 12 years: ask a doctor
- Children under 4 years: do not use
- Other Information
- Inactive Ingredients
FD&C Red No.40, FD&C Yellow No. 6, Gelatin, Glycerin, Poyethylene Glycol, Povidone, Propylene Glycol, Purified Water, Sorbitol Special, Titanium dioxide
Close - Questions or Comments
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
ACETAMINOPHEN,DEXTROMETHORPHAN,DOXYLAMINE
acetaminophen,dextromethorphan,doxylamine capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58805-003 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 DOXYLAMINE SUCCINATE (UNII: V9BI9B5YI2) (DOXYLAMINE - UNII:95QB77JKPL) DOXYLAMINE SUCCINATE 6.25 mg Inactive Ingredients Ingredient Name Strength FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) GELATIN (UNII: 2G86QN327L) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) SORBITOL (UNII: 506T60A25R) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) GLYCERIN (UNII: PDC6A3C0OX) Product Characteristics Color GREEN Score no score Shape CAPSULE Size 22mm Flavor Imprint Code 215 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58805-003-14 7680 in 1 BLISTER PACK 05/01/2014 1 1 in 1 CARTON; Type 0: Not a Combination Product 2 NDC:58805-003-04 180 in 1 BLISTER PACK 05/01/2014 2 1 in 1 CARTON; 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 05/01/2014 Labeler - Agile Pharmachem (650687853) Registrant - Agile Pharmachem (650687853)