NDC | 69772-440-01, 69772-440-02 |
Set ID | 1cbb8491-6ef7-45af-e054-00144ff88e88 |
Category | HUMAN OTC DRUG LABEL |
Packager | Teresa Cecena DBA Genesis |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- ACTIVE INGREDIENT
- PURPOSE
-
USER SAFETY WARNINGS
USES
Temporaruly relieves the symptoms due to common cold and allergies: Cough, nasal congestion, runny nose, sneezing, watery eyes, fever, aches and pains.
WARNINGS
DO NOT USE More than recommended dosage for pain more than 7 days for fever more than 3 days for children under 12 age with any other product containing acetaminophen.
-
WARNINGS AND PRECAUTIONS
Alcohol Warning:If you consume 3 or more alcoholic drinks every day, ask your doctor if you should take acetaminophen or other pain relivers fever reducers. Acetaminophen may casuse liver damage
Ask a doctor befor use you have
- Glaucoma, breathing problems such as emphysema or chronic bronchitis, heart disease, diabetes, thyroid disease.
- difficulty in urination due to enlagement of the prostate gland
Ask a doctor or pharmacist before use if you are taking tranquilizers or sedatives
Do not take this product for persistent or chronic cough such as occur with smoking, asthma or emphysema, or if cough is accompanied by excessive phlegm (mucis) unless directed by doctor
- STOP USE
-
WHEN USING
When using this product
- you may get drowsy avoid alcoholic drinks
- alcohol, sedatives and tranquilizers may increase drowsiness
- use caution when driving a motor vehicle or operating machinery
- excitabiloty may occur, especially in children
if nervousness, dizziness or spleeplessness occur discontinue use and consult a doctor
- ASK DOCTOR
- KEEP OUT OF REACH OF CHILDREN
-
DRUG INTERACTIONS
Drug unteraction precautions
do not use if you are taking a prescription monoamine oxidase ihibitor (MAOI) (certain drug for depression, psychoatric or emotional conditions, or parkinson's disease), or for 2 weeks after stopping the MAOI drug. If you do not know if your presctiption drug contains an MAOI, ask a doctor or pharmacist before taking this product.
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
- WARNINGS
- INDICATIONS & USAGE
-
INGREDIENTS AND APPEARANCE
XL3 XTRA
acetaminophen chloepheniramine maleate dextromethorphan phenylepherine hydrochloride capsule liquid filled capsule, liquid filledProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69772-440 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DEXTROMETHORPHAN HYDROBROMIDE (UNII: 9D2RTI9KYH) (DEXTROMETHORPHAN - UNII:7355X3ROTS) DEXTROMETHORPHAN HYDROBROMIDE 10 mg in 1 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg in 1 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 250 mg in 1 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg in 1 mg Inactive Ingredients Ingredient Name Strength D&C RED NO. 33 (UNII: 9DBA0SBB0L) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) GELATIN (UNII: 2G86QN327L) GLYCERIN (UNII: PDC6A3C0OX) POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9) POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621) POVIDONE (UNII: FZ989GH94E) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) WATER (UNII: 059QF0KO0R) Product Characteristics Color blue Score score with uneven pieces Shape CAPSULE (SOFT LIQUID FILLED CAPSULE) Size 10mm Flavor Imprint Code Xtra Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69772-440-01 20 mg in 1 BLISTER PACK; Type 0: Not a Combination Product 09/02/2015 2 NDC:69772-440-02 12 mg in 1 BLISTER PACK; Type 0: Not a Combination Product 09/02/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part341 08/07/2015 Labeler - Teresa Cecena DBA Genesis (078760958) Registrant - Teresa Cecena (078760958) Establishment Name Address ID/FEI Business Operations TERESA CECENA 078760958 relabel(69772-440) Establishment Name Address ID/FEI Business Operations Selder SA DE CV 824413629 manufacture(69772-440)