Label: EFFERVESCENT ORANGE COLD RELIEF- aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
- NDC Code(s): 55910-769-20
- Packager: DOLGENCORP, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Updated April 26, 2021
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- Active Ingredients
Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye’s syndrome, a rare but serious illness.
Allergy alert: Aspirin may cause a severe allergic reaction which may include: ■ hives ■ facial swelling ■ asthma (wheezing) ■ shock
Stomach bleeding warning: This product contains a non-steroidal anti-inflammatory drug (NSAID), which may cause severe stomach bleeding. The chance is higher if you
■ are age 60 or older ■ have had stomach ulcers or bleeding problems ■ take a blood thinning (anticoagulant) or steroid drug ■ take other drugs containing prescription or non-prescription NSAIDs (aspirin, ibuprofen, naproxen, or others) ■ have 3 or more alcoholic drinks every day while using this product ■ take more or for a longer time than directed
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
■ if you have ever had an allergic reaction to any other pain reliever/fever reducer
■ if you are allergic to aspirin ■ 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
■ stomach bleeding warning applies to you ■ you have a history of stomach problems such as heartburn ■ you have high blood pressure, heart disease, liver cirrhosis, or kidney disease ■ you are taking a diuretic ■ if you are taking sedatives or tranquilizers
You have ■ glaucoma ■ diabetes ■ thyroid disease ■ trouble urinating due to an enlarged prostate gland ■ a breathing problem such as emphysema or chronic bronchitis ■ been placed on a sodium-restricted diet
- Ask a doctor or pharmacist before use if you are
When using this product
do not take more than 8 tablets (adults and children 12 years and over) in a 24-hour period or as directed by a doctor.
■ do not use more than directed
■ you may get drowsy
■ avoid alcoholic drinks
■ excitability may occur, especially in children
■ alcohol, sedatives and tranquilizers may increase drowsiness
■ be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if
■ you experience any of the following signs of stomach bleeding
■ feel faint ■ vomit blood ■ have bloody or black stools ■ have stomach pain that does not get better
■ an allergic reaction occurs. Seek medical help right away.
■ pain or nasal congestion gets worse or lasts more than 7 days
■ fever gets worse or lasts more than 3 days
■ new symptoms occur
■ redness or swelling is present
■ ringing in the ears or a loss of hearing occurs
■ nervousness, dizziness or sleeplessness occurs
- If pregnant or breastfeeding,
- Keep out of reach of children
- In case of overdose,
- Other information
- Inactive ingredients
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
EFFERVESCENT ORANGE COLD RELIEF
aspirin, chlorpheniramine maleate, phenylephrine bitartrate tablet, effervescent
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55910-769 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PHENYLEPHRINE BITARTRATE (UNII: 27O3Q5ML57) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE BITARTRATE 7.8 mg ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN 325 mg CHLORPHENIRAMINE MALEATE (UNII: V1Q0O9OJ9Z) (CHLORPHENIRAMINE - UNII:3U6IO1965U) CHLORPHENIRAMINE MALEATE 2 mg Inactive Ingredients Ingredient Name Strength ACESULFAME POTASSIUM (UNII: 23OV73Q5G9) ANHYDROUS CITRIC ACID (UNII: XF417D3PSL) ASPARTAME (UNII: Z0H242BBR1) DOCUSATE SODIUM (UNII: F05Q2T2JA0) FD&C RED NO. 40 (UNII: WZB9127XOA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) MANNITOL (UNII: 3OWL53L36A) POVIDONE K30 (UNII: U725QWY32X) SODIUM BENZOATE (UNII: OJ245FE5EU) SODIUM BICARBONATE (UNII: 8MDF5V39QO) Product Characteristics Color white Score no score Shape ROUND Size 25mm Flavor ORANGE Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55910-769-20 10 in 1 CARTON 09/15/2015 1 2 in 1 POUCH; 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 09/15/2015 Labeler - DOLGENCORP, LLC (068331990)