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NDC 36800-0768-20 Effervescent Cold Relief 325; 2; 7.8 mg/1; mg/1; mg/1 Details
Effervescent Cold Relief 325; 2; 7.8 mg/1; mg/1; mg/1
Effervescent Cold Relief is a ORAL TABLET, EFFERVESCENT in the HUMAN OTC DRUG category. It is labeled and distributed by Topco Associates LLC. The primary component is ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE.
Product Information
NDC | 36800-0768 |
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Product ID | 36800-768_d04a5435-c302-5722-e053-2995a90a8b12 |
Associated GPIs | 43994003080830 |
GCN Sequence Number | n/a |
GCN Sequence Number Description | n/a |
HIC3 | n/a |
HIC3 Description | n/a |
GCN | n/a |
HICL Sequence Number | n/a |
HICL Sequence Number Description | n/a |
Brand/Generic | n/a |
Proprietary Name | Effervescent Cold Relief |
Proprietary Name Suffix | n/a |
Non-Proprietary Name | Aspirin, Chlorpheniramine Maleate, Phylephrine Bitartrate |
Product Type | HUMAN OTC DRUG |
Dosage Form | TABLET, EFFERVESCENT |
Route | ORAL |
Active Ingredient Strength | 325; 2; 7.8 |
Active Ingredient Units | mg/1; mg/1; mg/1 |
Substance Name | ASPIRIN; CHLORPHENIRAMINE MALEATE; PHENYLEPHRINE BITARTRATE |
Labeler Name | Topco Associates LLC |
Pharmaceutical Class | Adrenergic alpha1-Agonists [MoA], Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor An |
DEA Schedule | n/a |
Marketing Category | OTC MONOGRAPH FINAL |
Application Number | part341 |
Listing Certified Through | 2024-12-31 |
Package
Package Images

NDC 36800-0768-20 (36800076820)
NDC Package Code | 36800-768-20 |
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Billing NDC | 36800076820 |
Package | 10 POUCH in 1 CARTON (36800-768-20) / 2 TABLET, EFFERVESCENT in 1 POUCH |
Marketing Start Date | 2010-07-01 |
NDC Exclude Flag | N |
Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL a2929bcb-fa81-4f15-b087-a9996b5e7d1f Details
Active ingredients
Active ingredients
(in each effervescent tablet) . . . . . . . . . . .Purpose
Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . .Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg . . . . . . . . . . . . Antihistamine
Phenylephrine Bitartrate 7.8 mg . . . . . . . . . . .Nasal decongestant
*Nonsteroidal anti-inflammatory drug
Purpose
(in each effervescent tablet) . . . . . . . . . . . Purpose
Aspirin 325 mg (NSAID)*. . . . . . . . . . . . . . . . . . .Pain reliever/fever reducer
Chlorpheniramine maleate 2 mg . . . . . . . . . . . . Antihistamine
Phenylephrine Bitartrate 7.8 mg . . . . . . . . . . .Nasal decongestant
*Nonsteroidal anti-inflammatory drug
Uses
Warnings
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 an 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 nonprescription 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
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. ■ if you have ever had an allergic reaction to this product or any of its ingredients.
Ask a doctor before use if
Ask a doctor before use if you have
Ask a doctor or pharmacist before use if you are
When using this product
Stop use and ask a doctor if
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 breast-feeding
In case of overdose
Directions
Other information
Inactive ingredients
INGREDIENTS AND APPEARANCE
EFFERVESCENT COLD RELIEF
aspirin, chlorpheniramine maleate, phylephrine bitartrate tablet, effervescent |
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Labeler - Topco Associates LLC (006935977) |