NDC | 69168-270-95 |
Set ID | b04b96e0-d99b-48d1-b8b8-e2fdd8dd3f5f |
Category | HUMAN OTC DRUG LABEL |
Packager | Allegiant Health |
Generic Name | |
Product Class | alpha-1 Adrenergic Agonist |
Product Number | |
Application Number | PART341 |
- Active ingredient (in each caplet)
- Purpose
- Uses
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Warnings
Liver warning/Allergy alert
Liver warning: This product contains acetaminophen.
Severe liver damage may occur if you take
- more than 4,000mg of acetaminophen in 24 hours
- with other drugs containing acetminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert: Acetaminophen may cause severe skin reactions.
Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
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 using this product.
- if you have ever had an allergic reaction to this product or any of its ingredients
Ask a doctor before use if you have
- liver disease
- heart disease
- high blood pressure
- thyroid disease
- diabetes
- trouble urinating due to an enlarged prostate
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
When using this product
When using this product do not exceed recommended dose
- Keep Out of Reach of Children
- Directions
- Inactive Ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
SINUS HEADACHE PEMAXIMUM STRENGTH NON-DROWSY MAXIMUM STRENGTH NON-DROWSY
acetaminophen and phenylephrine hcl tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-270 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 325 mg PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) HYPROMELLOSES (UNII: 3NXW29V3WO) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) CROSPOVIDONE (UNII: 2S7830E561) Product Characteristics Color ORANGE Score no score Shape CAPSULE Size 17mm Flavor Imprint Code AZ270 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-270-95 18 in 1 BLISTER PACK; Type 0: Not a Combination Product 12/22/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH FINAL part341 12/22/2014 Labeler - Allegiant Health (079501930)